MedWorm.com provides a medical RSS filtering service. Over 6000 RSS medical sources are combined and output via different filters. This feed contains the latest items from the 'BioHealth Investor' source. Thu, 09 Feb 2012 01:31:29 +0100 http://www.medworm.com/index.php?rid=5546257&cid=s_35775_34_f&fid=35775&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FBiohealthInvestor%2F%7E3%2Fxa54_1qk3Uw%2Fcan-human-genome-really-double-its-stock-price-hgsi.html At the end of December, we usually review the biotech sector to see which stocks have the most upside for the year ahead.  The basis of the “implied upside” is the consensus mean estimate from Thomson Reuters.  Sometimes the pack of analysts is very right, and sometimes they all get blind-sided.  It was interesting to see that Human Genome Sciences, Inc. (NASDAQ: HGSI) was the top biotech and biohealth related stock as far as implied upside for the year ahead.  Perhaps the upside is because analysts were caught off their feet over the doctor-patient adoption despite that no new lupus treatment had been given FDA approval in years.  Perhaps it is now that more clarification is coming on the reimbursement and recommended drugs from physicians. Either way, this was what biote... BioHealth Investor news http://www.medworm.com/rss/comments.php?id=5546257 Wed, 28 Dec 2011 14:30:00 +0100 5546257 http://www.medworm.com/index.php?rid=5402238&cid=s_35775_34_f&fid=35775&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FBiohealthInvestor%2F%7E3%2FWr37ZT6J7iE%2Falimera-implosion-analysis-what-is-next-alim-psdv.html Alimera Sciences, Inc. (NASDAQ: ALIM) is the latest of the drug implosions and this one looks even worse than just severely damaging.  The FDA’s complete response letter is really a request for additional data.  This is almost as bad as it could be, short of an outright rejection with an order of termination, for its diabetic macular edema (vision-loss for diabetics) drug candidate called ILUVIEN.  The reason the stock was down so much (almost 75%) is because we can’t see how the company can adequately fund the next trial and the next trial after that.  One trial, maybe. Two, no way.  The company had less than $39 million in cash on hand as of the end of September and its quarterly loss was $6.5 million in the last quarter even though its R&D expenses were lower.  Th... BioHealth Investor news http://www.medworm.com/rss/comments.php?id=5402238 Fri, 11 Nov 2011 21:17:03 +0100 5402238 http://www.medworm.com/index.php?rid=5391357&cid=s_35775_34_f&fid=35775&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FBiohealthInvestor%2F%7E3%2FOzTsWAjg24I%2Fimplosion-analysis-for-targacept-what-lies-ahead-trgt-azn.html Tuesday has been an awful day for shareholders of Targacept Inc. (NASDAQ: TRGT).  The company shares lost more than half of their value on news that initial test results from the Phase III antidepressant (TC-5214) failed to meet their endpoints in treating major depressive disorder.  Targacept is covered under a co-development pact with AstraZeneca PLC (NYSE: AZN) in the United Kingdom and this is supposed to be an add-on treatment for patients where primary treatment was not adequate. Effectively, this was the first of four Phase III trials and more data on all of the results should come by the first half of 2012.  What is amazing is that the companies have said that they still hope to file for FDA approval in the United States during the second half of 2012.  Depression treatment is ... BioHealth Investor news http://www.medworm.com/rss/comments.php?id=5391357 Tue, 08 Nov 2011 18:58:30 +0100 5391357 http://www.medworm.com/index.php?rid=5391358&cid=s_35775_34_f&fid=35775&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FBiohealthInvestor%2F%7E3%2FyDPI7Yg0Tb4%2Frare-analyst-calls-with-huge-upside-in-vical-and-vivus-vicl-vvus-bmy.html Vical Inc. (NASDAQ: VICL) and VIVUS, Inc. (NASDAQ: VVUS) are both running higher this Friday on news that Credit Suisse initiated both biotech outfits with “Outperform” ratings.  What matters more than the call are the price targets and the inferences made in the research calls. Vical Inc. (NASDAQ: VICL) is rarely given huge analyst calls due to what is a small $250 million or so in market cap.  The team at Credit Suisse initiated Vical with an “Outperform” rating this morning but more important is its price target of $7.00 per share.  This represents more than a 100% move compared to the $3.45 close on Thursday.   What was more impressive was the $7.00 price target versus a $3.45 close before, indicating just over 100% upside. Credit Suisse noted that Vical&#8... BioHealth Investor news http://www.medworm.com/rss/comments.php?id=5391358 Fri, 04 Nov 2011 15:25:53 +0100 5391358 http://www.medworm.com/index.php?rid=5339076&cid=s_35775_34_f&fid=35775&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FBiohealthInvestor%2F%7E3%2FazMcj_KK0sA%2Ftop-biotechs-with-upside-ahead-of-earnings-gild-amln-aria-incy-jazz-dndn-hgsi-ilmn-amgn-celg-biib-bmrn-life-regn-amln-cbst-onxx-thrx-vphm.html Earnings season is afoot and we wanted to see how the analysts are ranking the top biotech stocks before these companies begin their earnings reports.  We pulled the top biotech and biohealth related stocks which have market caps of $1 billion and higher and we broke these out into three separate groups by size.  The large-cap biotechs are ranked in descending order by size.  The stocks under $10 billion in market cap and then under $3 billion were broken out in alphabetical order.  We have compiled some color on selected names, but we also listed the current trading prices, the implied price targets from Thomson Reuters, gave multiples of earnings estimates (from Thomson Reuters) for the forward year (2012 in most cases), showed the trading history and listed a price-to-book ratio.  ... BioHealth Investor news http://www.medworm.com/rss/comments.php?id=5339076 Wed, 19 Oct 2011 12:34:32 +0100 5339076 http://www.medworm.com/index.php?rid=5326155&cid=s_35775_34_f&fid=35775&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FBiohealthInvestor%2F%7E3%2FQIpcbSEekf4%2Fodds-making-on-a-human-genome-sciences-acquisition-hgsi-gsk-biib-mrk.html Human Genome Sciences Inc. (NASDAQ: HGSI) is surging on reports that GlaxoSmithKline PLC (NYSE: GSK) could be set to make a $25.00 per share offer to acquire the company.  The report surfaced in the Daily Mail out of the United Kingdom, and we would note that this publication pushes out enough rumors that it could be called the Daily Rumor (or Rumour for the Brits).  It also has a spotty track record. The reason for the speculation is simple… GSK was long thought of to be the natural buyer because of the long pacts that are in place already.  The two already have Benlysta as the lupus treatment under a collaboration pact.  Then there is the issues of HGS’s pipeline. What is interesting is that the Daily Mail also threw out Biogen Idec Inc. (NASDAQ: BIIB) and Merck & Co.... BioHealth Investor news http://www.medworm.com/rss/comments.php?id=5326155 Tue, 18 Oct 2011 17:19:29 +0100 5326155 http://www.medworm.com/index.php?rid=5317566&cid=s_35775_34_f&fid=35775&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FBiohealthInvestor%2F%7E3%2FejcTih2Iqtk%2Funusual-analyst-upgrade-endorsement-for-cell-therapeutics-ctic.html Cell Therapeutics, Inc. (NASDAQ: CTIC) is a controversial stock in the field of cancer and the company is still aiming for a 2012 debut market launch for its pixantrone drug candidate.  In the last couple of weeks it had reported more positive data and the FDA had earlier this year noted that pixantrone would need a review using a new panel of independent radiologists.  Pixantrone is to be a new treatment for non-Hodgkin Lymphoma.   This morning we saw a very unlikely and very unusual support or endorsement of Cell Therapeutics.  This came from Zacks Investment Research where the outfit was called The Bull of The Day.  That is generally considered a stock that has strong winds behind it and Zacks raised the rating to Outperform. Zacks noted, “we believe pixantrone is getting clo... BioHealth Investor news http://www.medworm.com/rss/comments.php?id=5317566 Thu, 13 Oct 2011 13:05:32 +0100 5317566 http://www.medworm.com/index.php?rid=5276952&cid=s_35775_34_f&fid=35775&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FBiohealthInvestor%2F%7E3%2FCmemPDuwrw4%2Fprivate-equity-changes-cro-landscape-with-ppd-buyout-ppdi-crl-cvd-prxl.html The world of contract research organizations is changing.  The unexpected news hit the wire this Monday that Pharmaceutical Product Development, Inc. (NASDAQ: PPDI) is being acquired.  This was no gobble-up acquisition where a larger public company preyed on a smaller company.  This was a private equity transaction. PPD has entered into a definitive merger agreement to be acquired in a $3.9 billion cash buyout by affiliates of The Carlyle Group and Hellman & Friedman.  The terms of the deal call for the assumption of liabilities and for the common holders to receive $33.25 per share in cash.  Before today, the trading range had effectively been $25 to $32 but the stock closed at $25.66 on Friday and that implies a near-30% premium. PPD has also been north of $40 in the last 5-year... BioHealth Investor news http://www.medworm.com/rss/comments.php?id=5276952 Mon, 03 Oct 2011 13:56:45 +0100 5276952 http://www.medworm.com/index.php?rid=5228965&cid=s_35775_34_f&fid=35775&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FBiohealthInvestor%2F%7E3%2F_kXvXsVP6mE%2Fmore-signs-of-life-for-obesity-drugs-vvus-orex-arna.html VIVUS Inc. (NASDAQ: VVUS) is getting yet one more sign of life for its Qnexa drug aimed at treating obesity.  The emerging drug outfit has reached an agreement with the FDA on resubmitting its new drug application as an obesity treatment. Here is the plan: “VIVUS intends to resubmit the QNEXA NDA by the end of October 2011, prior to completion of the FORTRESS study. Top-line results from FORTRESS are expected in December 2011, with validation of FORTRESS expected in the third quarter of 2012. The FDA also stated that an Advisory Committee meeting for QNEXA will be held in the first quarter of 2012.” It was also just earlier this week that its Avanafil phase III study results were shown again to be positive in its REVIVE study in diabetes. What helps VIVUS here is that treating... BioHealth Investor news http://www.medworm.com/rss/comments.php?id=5228965 Thu, 15 Sep 2011 15:25:26 +0100 5228965 http://www.medworm.com/index.php?rid=5099552&cid=s_35775_34_f&fid=35775&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FBiohealthInvestor%2F%7E3%2FQ3aa3lgm1Qc%2Fbeyond-the-dendreon-implosion-what-to-look-for-next-dndn.html This morning we gave a full preliminary analysis of the implosion happening at Dendreon Corporation (NASDAQ: DNDN) at 24/7 Wall St.  What is obvious as a heart attack, or as obvious as metastatic prostate cancer, is that the market is bracing for far worse news than what has been seen so far.  The price drop after withdrawal of guidance and the cost cutting only happens this far when another shoe is expected to fall. We have seen many analysts come in on this today, mostly calls which are blow-ups.  To say that Dendreon caught most of the market off balance would be a severe understatement. We also believed that this was going to become the standard for final-stage prostate cancer care. Here is what Wall Street analysts are making calls on today: Raised to Neutral at Credit Suisse, but... BioHealth Investor news http://www.medworm.com/rss/comments.php?id=5099552 Thu, 04 Aug 2011 14:20:58 +0100 5099552 http://www.medworm.com/index.php?rid=4988282&cid=s_35775_34_f&fid=35775&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FBiohealthInvestor%2F%7E3%2FpGcdUv_SUQE%2Fmedicare-coverage-capitulation-a-win-for-dendreon-provenge-dndn.html Dendreon Corporation (NASDAQ: DNDN) is indicated higher this morning on news that came out last night.  The company announced support for broad availability for on-label use of Provenge for asymptomatic or minimally symptomatic metastatic castrate resistant prostate cancer.  The FDA also this week approved Dendreon’s Los Angeles immunotherapy manufacturing facility with 36 workstations.  The big win is Medicare coverage. Dendreon reported that the Centers for Medicare and Medicaid Services issued a final coverage decision for PROVENGE that will require Medicare contractors to cover the use of PROVENGE for treatment of asymptomatic or minimally symptomatic metastatic castrate resistant prostate cancer. The coverage decision will standardize coverage processes across the country for... BioHealth Investor news http://www.medworm.com/rss/comments.php?id=4988282 Fri, 01 Jul 2011 11:32:54 +0100 4988282 http://www.medworm.com/index.php?rid=4972199&cid=s_35775_34_f&fid=35775&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FBiohealthInvestor%2F%7E3%2FuGvt-Tlqy3k%2Fmore-buyout-and-ma-candidates-in-biohealth-incy-lly-nvs-celg-cadx-hsp-slxp.html It seems that if there is one segment that everyone agrees will continue to see consolidation, it is the biotech, drug, and specialty pharmaceutical sector.  A report this week from UBS has highlighted several possible deals that it could imagine from its universe of analysts and there were four possible deals in biotech and pharma that were touted and which we think were worth mentioning. The companies covered as possible targets were Incyte Corporation (NASDAQ: INCY), Celgene Corporation (NASDAQ: CELG), Cadence Pharmaceuticals Inc. (NASDAQ: CADX), and Salix Pharmaceuticals Ltd. (NASDAQ: SLXP).  We have sort of handicapped each scenario with our own outlook and shown how these compare to an overall analyst consensus. Incyte Corporation (NASDAQ: INCY) is called a biotech takeover target ... BioHealth Investor news http://www.medworm.com/rss/comments.php?id=4972199 Mon, 27 Jun 2011 22:11:56 +0100 4972199 http://www.medworm.com/index.php?rid=4972200&cid=s_35775_34_f&fid=35775&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FBiohealthInvestor%2F%7E3%2Fbww2LvqF_n4%2Fwhat-pfizer-would-get-from-icagen-pfe-icgn.html Icagen Inc. (NASDAQ: ICGN) is one of the smaller biohealth companies out there and it is often overlooked by investors.  When headlines hit that Pfizer Inc. (NYSE: PFE) may be interested in acquiring the company, you know what happened… Shares skyrocketed. What we want to know is if the deal could be worth it now that the biotech outfit has seen shares more than double in a single session. Pfizer has said it was considering a strategic transaction with the company, and it needs to be known that Pfizer already is a stakeholder in the company. Icagen is also reportedly engaged in discussions. What is amazing is that Icagen had a market capitalization of only about $18 million before the news, and now that is listed as $38.9 million after a 116% gain to $5.19.  MILLION… not bill... BioHealth Investor news http://www.medworm.com/rss/comments.php?id=4972200 Mon, 27 Jun 2011 16:44:44 +0100 4972200 http://www.medworm.com/index.php?rid=4963649&cid=s_35775_34_f&fid=35775&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FBiohealthInvestor%2F%7E3%2FghAD8PvOYbg%2Fcancer-ipo-filing-clovis-oncology-clvs-celg-pfe.html Clovis Oncology, Inc. has filed for an initial public offering.  The company plans to list on the NASDAQ Global Market under the stock symbol “CLVS.”  Financial terms were not disclosed, but Clovis listed that the proposed maximum to be sold in shares is up to $149,500,000.00. Book-runners are listed as J.P. Morgan and Credit Suisse; and the co-manager is Leerink Swann. Clovis is a biopharmaceutical outfit focused on acquiring, developing and commercializing innovative anti-cancer agents in the United States, Europe and additional international markets.  The target arena are development programs in subsets of cancer populations. The company currently is developing three product candidates where it holds global marketing rights: CO-101, a lipid-conjugated form of the anti-ca... BioHealth Investor news http://www.medworm.com/rss/comments.php?id=4963649 Fri, 24 Jun 2011 10:30:06 +0100 4963649 http://www.medworm.com/index.php?rid=4963650&cid=s_35775_34_f&fid=35775&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FBiohealthInvestor%2F%7E3%2FBFh6V9CVVgk%2Fthe-next-blockbuster-drug-pfe-bmy-bayry-jnj-sny.html Against a backdrop of falling stock prices, Pfizer Inc. (NYSE: PFE) and Bristol-Myers Squidd company (NYSE: BMY) have bucked the trend of the day and both are seeing a rise in their share prices after reporting that “apixiban” has tested as being superior to and safer than the generic drug “warfarin.”   Both drugs are intended to aid in preventing strokes in patients with dangerously irregular heart rhythms.  “Apixiban” is the experimental blood thinner being developed by both Pfizer and Bristol Myers.  “Warfarin” is the generic version of Coumadin, whose patent expired more than 10 years ago. The hope is that this will lead to another blockbuster drug with more than $1 billion in sales.  The timing couldn’t be better for the two companies as Big Pharma companies are... BioHealth Investor news http://www.medworm.com/rss/comments.php?id=4963650 Thu, 23 Jun 2011 17:28:36 +0100 4963650 http://www.medworm.com/index.php?rid=4948094&cid=s_35775_34_f&fid=35775&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FBiohealthInvestor%2F%7E3%2FZga_rF8Zgwc%2Fhas-biogen-idec-become-too-expensive-biib.html Biogen Idec Inc. (NASDAQ: BIIB) is up nearly 4% today on news that ISI Group raised its rating to BUY from HOLD.  The driving force is Biogen’s promising MS drug candidate BG-12 with the belief that earnings can grow exponentially in the years ahead.  If one company has a lock on the MS market, it is Biogen Idec. The report today has shares up nearly 4% at $98.47 late in the day.  The consensus analyst price target is $104.13 and the 52-week trading range is $46.15 to $106.99. Our take is that the consensus price target objective of $104.13 is just not enough upside to merit a new purchase for a biotech giant.  We will be the first to admit that consensus price targets are very far from perfect.  In early January, Biogen Idec was “Overvalued” if you just used the pro... BioHealth Investor news http://www.medworm.com/rss/comments.php?id=4948094 Mon, 20 Jun 2011 19:51:11 +0100 4948094 http://www.medworm.com/index.php?rid=4916276&cid=s_35775_34_f&fid=35775&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FBiohealthInvestor%2F%7E3%2FWmHXjhdpDxw%2Fgileads-doj-subpoena-criminal-aspects-at-hand-gild.html Gilead Sciences, Inc. (NASDAQ: GILD) has been fighting an image of being “dead money” for biotech investors for a year.  Now the company has disclosed after the close on Friday that it has received a subpoena from the Department of Justice. The exact office is the United States Attorney’s Office for the Northern District of California. We actually have very little as to what the details are but the company said that the DOJ has requested documents related to the manufacture, and related quality and distribution practices of the company.  Specifically noted were Atripla®, Emtriva®, Hepsera®, Letairis®, Truvada®, Viread® and its investigational fixed-dose combination of Truvada and EdurantTM. Here is where the issues is going to arise… Gilead said that it “i... BioHealth Investor news http://www.medworm.com/rss/comments.php?id=4916276 Fri, 10 Jun 2011 21:12:11 +0100 4916276 http://www.medworm.com/index.php?rid=4916277&cid=s_35775_34_f&fid=35775&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FBiohealthInvestor%2F%7E3%2FQkdN3YrXnVE%2Flarge-fund-manager-sticks-with-valeant-vrx.html Valeant Pharmaceuticals International, Inc. (NYSE: VRX) is trading higher this morning by 1.5% at $53.15 against its 52-week range of $13.84 to $55.00.  This company is one which does not show up on most drug, biotech, and Pharma screens because its shares have risen, its analyst coverage is mixed, and its value is massive at $15+ billion. Fund managers often can influence investing decisions by the public and one top fund at the moment is the $4+ billion Sequoia Fund (SEQUX).  That fund has performed very well, it makes concentrated equity bets, and its biggest bet at the moment is Valeant.  This fund goes after companies that it believes have attractive long-term economic prospects in America or internationally. Waiting on a FDA decision is always tricky, but the FDA has a pending rev... BioHealth Investor news http://www.medworm.com/rss/comments.php?id=4916277 Thu, 09 Jun 2011 15:45:30 +0100 4916277 http://www.medworm.com/index.php?rid=4906872&cid=s_35775_34_f&fid=35775&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FBiohealthInvestor%2F%7E3%2Ffge2mv-fy1s%2Fkey-2011-asco-plays-agen-aria-bpax-celg-ghdx-rxii-sgen-snss-vicl.html When you hear about the oncology conference of the American Society of Clinical Oncology annual meeting in Chicago each year, you are probably drawn to what may be the next Genentech.  This is the conference that if good cancer and oncology study data can come out then it is likely to be presented here. We have broken down some of the key ASCO news bits, but these are in very abbreviated summaries in order to keep it from going on and on.   Antigenics Inc. (NASDAQ: AGEN), ARIAD Pharmaceuticals Inc. (NASDAQ: ARIA), BioSante Pharmaceuticals, Inc. (NASDAQ: BPAX), Celgene Corporation (NASDAQ: CELG), Genomic Health Inc. (NASDAQ: GHDX), Geron Corporation (NASDAQ: GERN), Incyte Corporation (NASDAQ: INCY), Oxigene Inc. (NASDAQ: OXGN), RXi Pharmaceuticals Corporation (NASDAQ: RXII), Seattle Gene... BioHealth Investor news http://www.medworm.com/rss/comments.php?id=4906872 Mon, 06 Jun 2011 14:39:38 +0100 4906872 http://www.medworm.com/index.php?rid=4867097&cid=s_35775_34_f&fid=35775&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FBiohealthInvestor%2F%7E3%2FqoYjB9j4VB4%2Fthe-other-side-of-the-coin-big-caution-in-dendreon-dndn.html Dendreon Corporation (NASDAQ: DNDN) is one we have been very positive about before the FDA approval of Provenge for metastatic prostate cancer.  We often like to feature both sides of the coin, and the other side of the coin is one of caution from Credit Suisse this week.  If this research call is right, shareholders could face some competitive pressure in shares of Dendreon. Credit Suisse has been very cautious when it comes to Dendreon Corporation (NASDAQ: DNDN).  The firm noted that an editorial in this week’s New England Journal of Medicine was published based upon Johnson & Johnson (NYSE: JNJ) and its abiraterone post-chemotherapy trial results.  What made the concern is the focus on results which validate abiraterone’s action.  Some may consider one article not a strong ... BioHealth Investor news http://www.medworm.com/rss/comments.php?id=4867097 Fri, 27 May 2011 16:07:37 +0100 4867097 http://www.medworm.com/index.php?rid=4835169&cid=s_35775_34_f&fid=35775&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FBiohealthInvestor%2F%7E3%2FFffgtaKQ1qE%2Fquestcelera-value-with-growth-dgx-cra.html Quest Diagnostics Inc. (NYSE: DGX) is a stock we have recently screened out for value investors who are looking for exposure to healthcare and now in genomics.  Some investors might not recognize the value on the current trailing 12-month P/E ratio, but there is value here in this diagnostics player.  Now the company has announced that it has completed its acquisition of Celera Corporation (NASDAQ: CRA). Many areas in healthcare are no longer as feared by investors as in 2008 and 2009.  It turns out that Obamacare has actually not crippled as many healthcare segments as feared.  If one area is going to remain afloat in the healthcare treatment segment it is diagnostics. Quest’s dividend is still less than 1% and that $0.10 quarterly payout has been in place since early-2006.  ... BioHealth Investor news http://www.medworm.com/rss/comments.php?id=4835169 Wed, 18 May 2011 10:37:01 +0100 4835169 http://www.medworm.com/index.php?rid=4816242&cid=s_35775_34_f&fid=35775&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FBiohealthInvestor%2F%7E3%2F16qIhvdYpe0%2Fanalysis-sizing-up-fda-approval-chances-of-obesity-drugs-vvus-orex-arna.html We have a new report sizing up obesity drugs this morning from Bank of America Merrill Lynch.  The long and short of the three ratings is that Orexigen Therapeutics, Inc. (NASDAQ: OREX) and Vivus, Inc. (NASDAQ: VVUS) are both rated ‘Buy’ at Bank of America Merrill Lynch, but Arena Pharmaceuticals, Inc. (NASDAQ: ARNA) is ‘Underperform’ rated.  As always, it is the devil in the details that offers the most insight. Vivus, Inc. (NASDAQ: VVUS) is finalizing its study design and the company’s President said efforts to finalize the trial design is assessing the risk of fetal malformations from Qnexa use in pregnant women.  The company will complete its retrospective analysis and re-file the Qnexa application by year-end. If the fetal malformation results are bad,... BioHealth Investor news http://www.medworm.com/rss/comments.php?id=4816242 Thu, 12 May 2011 12:45:59 +0100 4816242 http://www.medworm.com/index.php?rid=4808270&cid=s_35775_34_f&fid=35775&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FBiohealthInvestor%2F%7E3%2FBe0fOYWnLK0%2Fquest-for-1000-genome-complete-genomics-raises-expansion-capital-gnom.html COMPLETE GENOMICS, INC. (NASDAQ: GNOM) has filed to raise up to $75 million in cash in a public stock offering.  The filing is for 4.5 million shares, or it would be 5.175 million shares if the overallotment is exercised. The book-runners are Jefferies and UBS Investment Bank, and co-managers are Baird and Cowen & Co. Based upon the company’s name, you already figured out that they are in the genomics business.  It has a DNA sequencing platform and its goal is to “become the preferred solution for complete human genome sequencing and analysis” via its proprietary Complete Genomics Analysis Platform.  This allows academic and biopharmaceutical researchers a quality, cost-efficient and scale-efficient platform without having to invest in the expensive in-house sequ... BioHealth Investor news http://www.medworm.com/rss/comments.php?id=4808270 Tue, 10 May 2011 11:36:59 +0100 4808270 http://www.medworm.com/index.php?rid=4799385&cid=s_35775_34_f&fid=35775&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FBiohealthInvestor%2F%7E3%2FM2bKegvdsGw%2Falkermes-elan-game-changing-deal-for-both-companies-alks-eln-jnj-acor-amln-lly.html The biotech sector has been full of consolidation and mergers of late, but now we have a new model whereby a smaller company is set to grow by taking a part of a larger company.  We cannot exactly call it a reverse merger. Alkermes, Inc. (NASDAQ: ALKS) and Elan Corporation, plc (NYSE: ELN) have signed a definitive pact where Alkermes will merge with Elan’s unit called Elan Drug Technologies. The drug technologies unit is profitable and is the drug formulation and manufacturing unit.  The cash and stock transaction is valued toda at roughly $960 million and Alkermes and the unit will be combined under a new holding company structure that is incorporated in Ireland called Alkermes plc. Alkermes says this deal will be immediately accretive to cash earnings.  It also is said to accele... BioHealth Investor news http://www.medworm.com/rss/comments.php?id=4799385 Mon, 09 May 2011 11:10:47 +0100 4799385 http://www.medworm.com/index.php?rid=4772756&cid=s_35775_34_f&fid=35775&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FBiohealthInvestor%2F%7E3%2Fjq-5-BUUNVQ%2Fahead-of-earnings-analysts-fight-over-dendreon-dndn.html Dendreon Corporation (NASDAQ: DNDN) was just highlighted on Saturday morning as being on of the top analyst calls of the week because ThinkEquity had initiated coverage of Dendreon with a “Buy” rating at the firm with a price target objective of $50.00 per share. This Monday came a new analyst call from Credit Suisse that is almost the exact opposite.  Credit Suisse started coverage with an “Underperform” rating and only a $29.00 price target objective.  What makes both of these calls so important is that this is ahead of this week’s expected earnings report.  Credit Suisse was cautious on peak-Provenge sales, while ThinkEquity was positive on peak-Provenge sales. Dendreon earnings are due shortly and remains a story around guidance for late-2011 and into 2... BioHealth Investor news http://www.medworm.com/rss/comments.php?id=4772756 Mon, 02 May 2011 13:00:09 +0100 4772756 http://www.medworm.com/index.php?rid=4750171&cid=s_35775_34_f&fid=35775&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FBiohealthInvestor%2F%7E3%2FDwjAUoJ5qGE%2Fwhen-analysts-expect-shares-to-more-than-double-vicl-pran-bmy-amgn.html We recently have picked back up on searching for ten-baggers in the field of biotechnology and those companies tied to a broader “BioHealth” sector.  Ten-baggers are those which can rise tenfold, or 1,000% from their lows, and these are generally measured from an extreme low in the shares.  Occasionally you do get to see a legitimate Wall Street analyst calling for a stock to more than double.  That is exactly what we are seeing this morning in shares of Vical Inc. (NASDAQ: VICL).  Canaccord Genuity initiated coverage with a “BUY” rating and it assigned a whopping $8.00 price target objective based mostly upon its Allovectin-7 as a potential malignant melanoma treatment. Before we get too far into the Canaccord call, it was just recently that we issued a potenti... BioHealth Investor news http://www.medworm.com/rss/comments.php?id=4750171 Tue, 26 Apr 2011 17:16:30 +0100 4750171 http://www.medworm.com/index.php?rid=4637554&cid=s_35775_34_f&fid=35775&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FBiohealthInvestor%2F%7E3%2Fq487nEMEAHo%2Fprana-a-speculative-ten-bagger-scenario-pran.html This last week brought an interesting move in shares of Prana Biotechnology Ltd. (NASDAQ: PRAN).  On Friday we gave this coverage right at the open noting at 24/7 Wall Street that the stock was still worth a look for speculators despite a news pop followed by a capital raise that hurt the stock’s gain during the week.  This ADR is of a company based in Australia and its focus is Alzheimer’s, Parkinson’s, and Huntingston’s Diseases.  It is highly speculative by any measurement.  Prana effectively has no revenues and our take is that it will be highly reliant upon grants from governments, agencies, and other foundations and organizations or it will have to rely upon the capital markets or a partnership for more funding down the road.  The company saw shares su... BioHealth Investor news http://www.medworm.com/rss/comments.php?id=4637554 Sat, 26 Mar 2011 15:36:09 +0100 4637554 http://www.medworm.com/index.php?rid=4607813&cid=s_35775_34_f&fid=35775&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FBiohealthInvestor%2F%7E3%2FtFH-wrpeBqA%2Fwhy-celeras-buyout-makes-sense-cra-dgx-hgsi-affx-ghdx-gnom-rosg-hlcs.html If you would have said ten years ago that Celera Corporation (NASDAQ: CRA) would be acquired by Quest Diagnostics Inc. (NYSE: DGX), most investors would have said that you were off your rocker.  Celera was a leader in genomics at the time and it had a huge mountain of cash that made up much of its value. Celera’s Berkeley HeartLab unit has a proprietary lipid testing technology, esoteric testing capability, advanced therapy guidelines and patient support services.  The company is also focused on personalized disease management where it is “developing tests and services that identify a person’s inherent risk for a disease and may also characterize its biological basis, aiding selection among treatment options and monitoring treatment effectiveness.” The value of th... BioHealth Investor news http://www.medworm.com/rss/comments.php?id=4607813 Fri, 18 Mar 2011 13:35:50 +0100 4607813 http://www.medworm.com/index.php?rid=4597442&cid=s_35775_34_f&fid=35775&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FBiohealthInvestor%2F%7E3%2FbYmvbkIOY1o%2Fteva-raises-capital-teva.html Teva Pharmaceutical Industries Limited (NASDAQ: TEVA) is not exactly one of the first companies we would think of as offering a bond issue, and it might normally lead us to think that Teva was on the verge of making another acquisition.  The company is raising debt capital but it does not seem to be signaling any imminent deal is coming. The company’s finance unit is selling some $750 million with fixed and floating rates.  The floating tranche is said to be $500 million expected at about 50 basis points over LIBOR and the $250 million fixed piece had price talk of 70 to 75 basis points above Treasuries. This appears to be debt that can be used to refinance other debt coming due without tapping into the cash coffers.  The official use is “for general corporate purposes.&#822... BioHealth Investor news http://www.medworm.com/rss/comments.php?id=4597442 Wed, 16 Mar 2011 16:58:36 +0100 4597442 http://www.medworm.com/index.php?rid=4576190&cid=s_35775_34_f&fid=35775&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FBiohealthInvestor%2F%7E3%2FRtgJGGFJ68E%2Fkv-holders-pricing-backlash-seems-likely-kv-a.html When we first covered the rebirth of KV Pharmaceutical Co. (KV-A) for its Makena drug aimed to prevent premature birth, we knew this was going to be a home run due to FDA market exclusivity.  Premature births result in costs that run into the billions yearly to healthcare providers and insurers.  Now it seems very likely that there is going to be a backlash in the form of public outrage that works its way into both the legal system and the political outrage venues against the company.  A price hike seemed certain after getting FDA approval for exclusivity, but the degree of the gouging is going to be where the line gets drawn in the sand between high stakes capitalism and grand larceny.  Keep in mind that yours truly believes in and supports the belief that capitalism is the incentive ... BioHealth Investor news http://www.medworm.com/rss/comments.php?id=4576190 Sat, 12 Mar 2011 14:25:59 +0100 4576190 http://www.medworm.com/index.php?rid=4567807&cid=s_35775_34_f&fid=35775&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FBiohealthInvestor%2F%7E3%2FqNTR3q7yAVI%2Fbenlysta-approval-cheat-sheet-what-you-need-to-know-hgsi-gsk.html It is official… The FDA has approved Benlysta as the first new drug regimen for systemic lupus in  over 50 years.  Human Genome Sciences, Inc. (NASDAQ: HGSI) and partner GlaxoSmithKline plc (NYSE: GSK) are sure to have a Blockbuster on their hands.  The treatment is for the treatment of adult patients with active, autoantibody-positive systemic lupus erythematosus who are receiving standard therapy. We want to stress that analyst data is going to change greatly and we want a snapshot here of what this looks like before the change.  The side-effects have taken a lot of space, and those are just verbatim.  The rest after that is where the guts of the outlook is.  We have been keeping tabs on a few side-bar issues going into this approval and here is are some of the key issues we ... BioHealth Investor news http://www.medworm.com/rss/comments.php?id=4567807 Thu, 10 Mar 2011 01:17:48 +0100 4567807 http://www.medworm.com/index.php?rid=4509218&cid=s_35775_34_f&fid=35775&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FBiohealthInvestor%2F%7E3%2FrYszR-w1bTE%2Fanalyst-bulls-up-on-dendreon-dndn-amgn.html A bullish research call on Dendreon Corporation (NASDAQ: DNDN) by Gleacher & Co. has so far been unable to prevent some pullbacks along with a broader market that is spooked by international geopolitical events.  Still, the research does lend credence to further upside for Dendreon based on its Provenge.  While not a target in the research call, we would throw out that there is some new indication from Amgen Inc. (NASDAQ: AMGN) in the war against prostate cancer as well. Gleacher & Co. this morning initiated coverage of Dendreon with a “Buy” rating and assigned a $42.00 price target.  The report from analyst Ying Huang notes, “we are encouraged by the survey results indicating that 40%-50% of castration-resistant prostate cancer (CRPC) patients in the US will b... BioHealth Investor news http://www.medworm.com/rss/comments.php?id=4509218 Wed, 23 Feb 2011 17:19:29 +0100 4509218 http://www.medworm.com/index.php?rid=4491795&cid=s_35775_34_f&fid=35775&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FBiohealthInvestor%2F%7E3%2FpE-YKkCEoSE%2Fcell-therapeutics-back-at-the-capital-well-ctic.html Cell Therapeutics, Inc. (NASDAQ: CTIC) is one that many will have forgotten about or one that many wish they had forgotten about.  Now the company is in the news after announcing a  securities purchase agreement to sell securities in a registered offering to a single life sciences institutional investor. The company said that it may use a portion of the net proceeds to fund possible investments in, or acquisitions of, complementary businesses, technologies or products.  Cell Therapeutics noted here that it has recently engaged in limited discussions with third parties regarding such investments or acquisitions, but has no current agreements or commitments with respect to any investment or acquisition.  It may also use the proceeds for general corporate purposes, such as paying interest... BioHealth Investor news http://www.medworm.com/rss/comments.php?id=4491795 Fri, 18 Feb 2011 12:01:01 +0100 4491795 http://www.medworm.com/index.php?rid=4485966&cid=s_35775_34_f&fid=35775&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FBiohealthInvestor%2F%7E3%2FATkP09EMxpk%2Fdefining-the-contingent-value-rights-in-genzyme-genz-sny.html By now you already know about the confirmed acquisition by Sanofi-Aventis (NYSE: SNY) for Genzyme Corporation (NASDAQ: GENZ).  The companies have finally entered into a definitive agreement where Sanofi-Aventis will pay $74.00 per Genzyme share in cash along with a contingent value right. The deal comes to about $20.1 billion before the consideration of the contingent value right.  Genzyme shareholders will receive one Contingent Value Right for each share they own.  These are referred to as CVRs by the investment bankers and each CVR gives each holder the right to receive additional cash payments if specified milestones are reached related to Lemtrada™ or if a milestone related to production volumes in 2011 for Cerezyme® and Fabrazyme® is achieved. The value to each CVR is as follo... BioHealth Investor news http://www.medworm.com/rss/comments.php?id=4485966 Wed, 16 Feb 2011 11:38:05 +0100 4485966 http://www.medworm.com/index.php?rid=4461800&cid=s_35775_34_f&fid=35775&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FBiohealthInvestor%2F%7E3%2Fyts7c4OGgUo%2Facelrx-ipo-new-pain-management-on-the-way-acrx.html AcelRx Pharmaceuticals Inc. (NASDAQ: ACRX) has its IPO priced for at least 8 million shares at $5.00 per share.  The company is pre-revenue and makes a treatment systems for sudden pain management.  The interesting aspect is that more shares were sold than expected, but at a lower price. The company will use the proceeds from the offering for ongoing development and for the marketing efforts of its hand held painkiller delivery device. AcelRx is as also developing drugs to treat and manage pain associated with cancer as well as for mild sedation to be used by doctors for office treatments and procedures. Piper Jaffray & Co. is the sole book-running manager and Cowen and Company, Canaccord Genuity, and JMP Securities are the co-managers for the offering.  AcelRx has granted to the un... BioHealth Investor news http://www.medworm.com/rss/comments.php?id=4461800 Fri, 11 Feb 2011 12:30:54 +0100 4461800 http://www.medworm.com/index.php?rid=4430521&cid=s_35775_34_f&fid=35775&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FBiohealthInvestor%2F%7E3%2FlER-ezDvq9Y%2Fhighlighted-trouble-at-celgene-yet-value-is-near-celg.html Celgene Corporation (NASDAQ: CELG) is having a rough day.  There are some concerns being brought to light. This morning came a report from Zacks.com detailing Celgene as a current member of the exclusive Zacks #5 Rank List.  In short, Zachs named it as one of the “Stocks to Sell Now.” Zacks pointed out, “Celgene posted fourth quarter earnings of 65 cents per share on January 27, which came in 3% short of the average forecast. The Zacks Consensus Estimate for 2011 declined 7 cents to $3.02 per share over the past month as 6 analysts out of 11 cut back on expectations. Estimate for 2012 dipped 10 cents to $3.71 per share in a span of a week.” Last month, the company gave a longer-term forecast for 2011 earnings of $3.30 to $3.35 EPS on $4.4 to $4.5 billion in revenu... BioHealth Investor news http://www.medworm.com/rss/comments.php?id=4430521 Thu, 03 Feb 2011 19:21:41 +0100 4430521 http://www.medworm.com/index.php?rid=4421356&cid=s_35775_34_f&fid=35775&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FBiohealthInvestor%2F%7E3%2FwM1pt9MfT2k%2Fafter-orexigens-implosion-now-what-orex-vvus-arna-abt.html Orexigen Therapeutics, Inc. (NASDAQ: OREX) is beyond ugly after the FDA said that the company must now submit more trial data before its new diet pill Contrave may be cleared for sale.  The vote was 13-against versus 7-for votes and now the FDA is asking for another study on the drug’s cardiovascular risks. Outside FDA advisers said back in early December that the benefits of the weight loss exceed the dangers of a higher pulse and blood pressure, with the indication that a larger study targeted on risks of the heart might until after the final drug approval.  That wasn’t so. Both VIVUS Inc. (NASDAQ: VVUS) and Arena Pharmaceuticals Inc. (NASDAQ: ARNA) have been in a race with Orexigen to introduce the first approved diet pill for weight loss in a about a decade.  Now all of thes... BioHealth Investor news http://www.medworm.com/rss/comments.php?id=4421356 Tue, 01 Feb 2011 15:09:01 +0100 4421356 http://www.medworm.com/index.php?rid=4412813&cid=s_35775_34_f&fid=35775&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FBiohealthInvestor%2F%7E3%2F0vpuHb3mynk%2Fma-bonanza-for-drug-biotech-in-2011-mrk-pfe-alxn-dndn-hgsi-ceph-uthr-cadx-amag-sny-genz-amgn-bec-teva-sgmo-lly-alth-cbst-vvus-auxl-vrtx.html The game of predicting mergers and acquisitions in the biotech and in pharma sectors is not a new one.  The talk heats up, then it dies down.  A deal comes, followed by another deal, and the activity goes quiet.  This next week is likely to have at least more chatter in the biohealth sector for possible mergers and acquisitions after Barron’s gave a cover story called “The New Doctor in the House: Consolidation.” Barron’s noted that “as big drug firms buy up smaller, specialty outfits and their most innovative products, better pipelines and sales-force efficiency will boost profits.”  Here is the thing to consider: Barron’s did not really offer anything new or ground-breaking this weekend.  It will have rekindled some hope that M&A is comi... BioHealth Investor news http://www.medworm.com/rss/comments.php?id=4412813 Sat, 29 Jan 2011 15:07:59 +0100 4412813 http://www.medworm.com/index.php?rid=4384122&cid=s_35775_34_f&fid=35775&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FBiohealthInvestor%2F%7E3%2Fbm2bLoMkrDg%2Ftop-biohealth-research-calls-of-the-week-mnkd-pdli-ilmn-clda-mrk-pfe-lly-bmy-alxn-svnt-amgn.html There were some key research calls in biotech and biohealth shares this week.  Over in our “top five analyst calls of the week” at 24/7 Wall Street we noted how one firm came out in defense of MannKind Corporation (NASDAQ: MNKD) on its implosion this week and another call was highlighting the potential upside value that remains in PDL BioPharma, Inc. (NASDAQ: PDLI) despite its patent fight concerns.  There were many other standout calls though in analyst coverage this last week in biohealth: Illumina Inc. (NASDAQ: ILMN) has remained impressive after having been one of our “Best of Big BioHealth in 2010″ and was also at the start of the year listed as “an overvalued biohealth names with peers.” This week brought an analyst duel.  Citigroup raised its r... BioHealth Investor news http://www.medworm.com/rss/comments.php?id=4384122 Sat, 22 Jan 2011 16:44:08 +0100 4384122 http://www.medworm.com/index.php?rid=4374488&cid=s_35775_34_f&fid=35775&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FBiohealthInvestor%2F%7E3%2FtP3mugJMOwE%2Fwhat-to-expect-after-mannkinds-implosion-mnkd.html MannKind Corporation (NASDAQ: MNKD) is currently not looking kind nor like a very nice man(n).  Shares of the already-controversial MannKind are getting crushed after the FDA sent the company a ‘Complete Response Letter’ regarding its inhalable Afrezza for diabetes.  The FDA has requested two new clinical trials with its next generation inhaler.  One test is for Type I diabetes and the other is for Type II diabetes. The FDA request also wants more data the performance characteristics, as well as the usage, handling, shipment, and storage. While MannKind said it remains committed to working with the FDA, it is also disappointed.  That is an understatement of the year.  At 6:30 PM EST the after-hours reaction had shares down a whopping 43.5% at $5.15 on more than 2 million s... BioHealth Investor news http://www.medworm.com/rss/comments.php?id=4374488 Thu, 20 Jan 2011 00:05:19 +0100 4374488 http://www.medworm.com/index.php?rid=4311249&cid=s_35775_34_f&fid=35775&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FBiohealthInvestor%2F%7E3%2F9Vd4y2Yl_78%2Fopexas-surge-brings-more-ms-treatment-hope-opxa-biib-nvs.html Opexa Therapeutics, Inc. (NASDAQ: OPXA) is on fire this morning with investor interest. The company announced that it has successfully completed two End-of Phase 2 meetings with the FDA over its Tovaxin.  This is the company’s lead-product candidate and is said to be the first ever personalized T-cell therapy aimed as multiple sclerosis. The company believes that these FDA meetings put Opexa in position to move forward with a pivotal Phase 3 study of Tovaxin, which Opexa preparing for to being the Phase III study. A Phase 2b study of Tovaxin demonstrated overall clinical and disability benefits over the placebo group, including a clinically relevant decrease in the Annualized Relapse Rate and improvement in disability score.  Another benefit beyond the efficacy measures that the FD... BioHealth Investor news http://www.medworm.com/rss/comments.php?id=4311249 Wed, 05 Jan 2011 16:45:42 +0100 4311249 http://www.medworm.com/index.php?rid=4306809&cid=s_35775_34_f&fid=35775&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FBiohealthInvestor%2F%7E3%2F4blQ1wdcBx0%2F2011s-overvalued-big-biotech-names-amln-biib-exel-ilmn-jazz-mdvn-osir-sqnm.html It is already 2011 and we have begun the coverage of our annual outlook series.  We covered the best of 2010 and an outlook for big-biotech stocks with the most implied upside already. Sometimes it is important to know also which of the big biotech and biohealth names may be overvalued when it comes to analyzing the current price and valuation data.  We have compiled data on the active biotech stocks which have at least five analysts making price target calculations for a year ahead. What we found was that a whole slew of companies were trading above the Thomson Reuters mean consensus price target objectives.  That does not assure that the analysts are right, but it means that either the analysts will have to play catch-up with price hikes or that they will be considering downgrading th... BioHealth Investor news http://www.medworm.com/rss/comments.php?id=4306809 Tue, 04 Jan 2011 13:01:57 +0100 4306809 http://www.medworm.com/index.php?rid=4297704&cid=s_35775_34_f&fid=35775&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FBiohealthInvestor%2F%7E3%2FDYXkPgk8zUM%2Fbig-biotechs-with-the-most-upside-for-2011-amgn-gild-celg-hgsi-dndn-incy-acor.html Bioheath Investor is creating some ongoing outlook pieces as 2010 ends so we have an outline of what to expect for 2011.  We have already given the “Best of Big Biotech in 2010″ and now we want to focus on “The Big Biotechs With The Most Upside for 2011.”  Using “Big Biotech” implies market caps of those with a market cap of $1 billion or higher.  It was surprising that many of those big biotechs are actually trading much higher than their projected price targets. Our screen generated 7 of the pack with implied upside of more than 15% for 2011.  Those making the screen were Amgen Inc. (NASDAQ: AMGN), Gilead Sciences, Inc. (NASDAQ: GILD), Celgene Corporation (NASDAQ: CELG), Human Genome Sciences, Inc. (NASDAQ: HGSI), Dendreon Corporation (NASDAQ: DNDN... BioHealth Investor news http://www.medworm.com/rss/comments.php?id=4297704 Wed, 29 Dec 2010 18:28:16 +0100 4297704 http://www.medworm.com/index.php?rid=4297705&cid=s_35775_34_f&fid=35775&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FBiohealthInvestor%2F%7E3%2F9_N4IoerwDk%2Fdara-capital-raise-bites-holders-dara.html DARA BioSciences, Inc. (NASDAQ: DARA) has been voltile in recent trading sessions.  The company has announced that it has priced a public offering of up to 4800 units at a price of $1000 per unit to the public.  Thge effect of the raise is that this goes up to $4.8 million from a projected $4 million. Each unit consists of 1 share of Series A convertible preferred stock which is convertible into 400 shares of common stock, and it comes with a Class A Warrant to purchase 200 shares of common stock and a Class B Warrant to purchase 200 shares of common stock.  The Series A preferred stock is convertible at any time at the option of the holder into shares of our common stock at a conversion price of $2.50 per share. Ladenburg Thalmann & Co. acted as the exclusive placement agent for th... BioHealth Investor news http://www.medworm.com/rss/comments.php?id=4297705 Wed, 29 Dec 2010 13:58:19 +0100 4297705 http://www.medworm.com/index.php?rid=4290852&cid=s_35775_34_f&fid=35775&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FBiohealthInvestor%2F%7E3%2Fap1BjBB38UE%2Fthe-best-of-big-biohealth-in-2010-ilmn-itmn-incy-thrx-vphm.html 2010 has been an interesting year for biotech and biohealth investors.  While we have had far fewer of the ‘ten-bagger ambitions’ in 2010 with exponential gains, there have been many key winners.  In the “$5 billion and over” category of market caps, Illumina Inc. (NASDAQ: ILMN) is the surprise winner of the biohealth players.  In the $1 billion to to $5 billion category, we have several winners including shares of InterMune Inc. (NASDAQ: ITMN), Incyte Corporation (NASDAQ: INCY), Theravance Inc. (NASDAQ: THRX), and ViroPharma Inc. (NASDAQ: VPHM).  We have taken a look at what has driven the gains as well as what the prospects are for 2011 and beyond. Illumina Inc. (NASDAQ: ILMN) is sort of surprising in the $5 billion and higher category considering that it deve... BioHealth Investor news http://www.medworm.com/rss/comments.php?id=4290852 Mon, 27 Dec 2010 19:02:46 +0100 4290852 http://www.medworm.com/index.php?rid=4283097&cid=s_35775_34_f&fid=35775&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FBiohealthInvestor%2F%7E3%2FMVmhksaA0ho%2Fgileads-loss-maybe-intermunes-gain-gild-itmn.html Gilead Sciences, Inc. (NASDAQ: GILD) terminated its ARTEMIS-IPF Phase III trial which was ongoing for its ambrisentan in patients with idiopathic pulmonary fibrosis.  This is not one of those good halts.  The trial was halted due to lack of efficacy. This is potentially a huge win for InterMune Inc. (NASDAQ: ITMN).  We recently noted the situation driving it up and called it a quest for ten-baggers after Europe’s EMA adopted a positive opinion that recommended granting marketing approval for its Esbriet (pirfenidone) in adults for treating mild to moderate idiopathic pulmonary fibrosis.  That EMA decision was after the FDA in the United States rejected the drug despite a positive indication in a panel review. Last week there was a come-along analyst call in InterMune from Wedbush... BioHealth Investor news http://www.medworm.com/rss/comments.php?id=4283097 Thu, 23 Dec 2010 15:11:45 +0100 4283097 http://www.medworm.com/index.php?rid=4279335&cid=s_35775_34_f&fid=35775&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FBiohealthInvestor%2F%7E3%2F1cxOb2kTB1I%2Fbullish-2011-outlook-for-human-genome-hgsi.html Human Genome Sciences, Inc. (NASDAQ: HGSO) has received a positive research call from an analyst targeting upside in the shares.  Gleacher & Co. initiated coverage on the company with a BUY rating and a $30 TARGET PRICE.  The thesis is actually “Slow and steady wins the race.” Ying Huang, Ph.D, of Gleacher, sees Benlysta receiving a broad label and that concerns of a restrictive label is the key overhang today.  The belief is that the FDA will not completely restrict Benlysta in patients with severe active lupus nephritis and CNS lupus. The report predicts that the FDA will likely request the company conduct post-marketing studies.  It is bullish long-term, albeit with a slow initial launch, and it ultimately sees over $1 billion in global sales in 2014 that may peak at... BioHealth Investor news http://www.medworm.com/rss/comments.php?id=4279335 Wed, 22 Dec 2010 18:43:51 +0100 4279335 http://www.medworm.com/index.php?rid=4273851&cid=s_35775_34_f&fid=35775&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FBiohealthInvestor%2F%7E3%2FRQb7PrFnTK0%2Fvivus-takes-qnexa-obesity-fight-to-europe-vvus.html VIVUS Inc. (NASDAQ: VVUS) has done what was expected.  It is not going to bet its entire future on the US FDA regulatory process for its QNEXA obesity pill.  The company is applying for marketing approval in the European Union. The company filed its European Marketing Authorization application for QNEXA as a treatment for obesity.  The indications it filed for in the EU are for weight loss and maintenance of weight loss which should be used in conjunction with a lower calorie diet. The EMA review will follow a centralized marketing authorization procedure and the company noted that, if QNEXA is approved, that it could receive marketing authorization in all European Union nations possibly as soon as late-2011. VIVUS is not exploding higher on the news but shares are up.  After a $9.78 c... BioHealth Investor news http://www.medworm.com/rss/comments.php?id=4273851 Mon, 20 Dec 2010 13:38:53 +0100 4273851 http://www.medworm.com/index.php?rid=4269414&cid=s_35775_34_f&fid=35775&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FBiohealthInvestor%2F%7E3%2Fs2vxIkBJf8c%2Fintermune-and-the-ten-bagger-quest-idiopathic-pulmonary-fibrosis-itmn.html InterMune Inc. (NASDAQ: ITMN) was already known by many investors and was already a very volatile issue.  With shares having nearly doubled on key drug news, InterMune is back on the map.  You can almost hear the call for a ten-bagger alert from the year’s lows. The stock is soaring on news out of Europe that the EMA adopted a positive opinion that actually recommends granting marketing approval for its Esbriet (pirfenidone) in adults.  The indication is for treating mild to moderate idiopathic pulmonary fibrosis, a fatal lung disease.  The FDA in the United States rejected the drug despite a positive indication in a panel review. The benefits are a reduction in the rate of deterioration of lung function that is measured by a lower decline of what is called the “percent-pre... BioHealth Investor news http://www.medworm.com/rss/comments.php?id=4269414 Fri, 17 Dec 2010 15:23:03 +0100 4269414 http://www.medworm.com/index.php?rid=4261807&cid=s_35775_34_f&fid=35775&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FBiohealthInvestor%2F%7E3%2FieTrZA-CHBw%2Famgen-scores-indication-in-prostate-cancer-amgn-dndn.html Amgen Inc. (NASDAQ: AMGN) is running higher after reporting on Monday evening that denosumab did delay the spread of prostate cancer to bones.  The study opens up the possibility for another blockbuster revenue stream for the drug and then some with annual sales possibilities of more than $1 billion. Denosumab delayed the spread of prostate cancer by 4.2 months on average over the placebo group.  The study did not find a survival benefit.  The drug targets a RANK protein discovered by Amgen more than a decade ago, which works to break down old bone cells and replace them with new cells. Amgen said it plans to review the study data and will then meet with regulators before deciding whether or not to seek approval for a prostate cancer indication. The men in this last study were considere... BioHealth Investor news http://www.medworm.com/rss/comments.php?id=4261807 Tue, 14 Dec 2010 13:35:23 +0100 4261807 http://www.medworm.com/index.php?rid=4247508&cid=s_35775_34_f&fid=35775&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FBiohealthInvestor%2F%7E3%2F9Fu2m0jkAh4%2Fanalysis-of-real-value-of-beckman-coulter-in-buyout-bec.html Beckman Coulter, Inc. (NYSE: BEC) is on fire after announcing that it is for sale.  The company provides biomedical testing instrument systems, tests, and supplies for clinical laboratories worldwide.  We wanted to see what it can fetch in a sale to see if investors should hang around for more or whether they should take the money and run. Private equity firms are expected to be the buyers, although other industrial companies might have an interest.  Reports are out the Beckman Coulter has hired Goldman Sachs to help it explore its options. The shares closed at $57.09 Thursday and its market capitalization was just under $4 billion.  Shares are now magically at $72.75. 2010 has been a very rough year as its summer guidance punished shares with more than a 20% loss.  Its CEO also left ... BioHealth Investor news http://www.medworm.com/rss/comments.php?id=4247508 Fri, 10 Dec 2010 15:55:06 +0100 4247508 http://www.medworm.com/index.php?rid=4243565&cid=s_35775_34_f&fid=35775&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FBiohealthInvestor%2F%7E3%2FS2lUlRsKC50%2Fa-very-cautious-case-against-human-genome-hgsi-gsk.html It was just earlier this week in a broad call that Human Genome Sciences Inc. (NASDAQ: HGSI) saw a very positive research call in a sector initiation as its stock was initiated with an “Outperform” and a $31.00 price target by Credit Suisse.  Apparently, that was then and this is now.  A new research call almost reverses all of that with an opposite stance.  Cowen & Company initiated coverage of Human Genome Sciences with an “Underperform” rating this morning and the implied value puts the stock as being overvalued. More important than a formal rating is the target.  Cowen’s Eric Schmidt (no relation to Google’s Eric Schmidt) says that Human Genome Sciences could have a share price that is overvalued by the tune of 30% or even 35%. While expected... BioHealth Investor news http://www.medworm.com/rss/comments.php?id=4243565 Thu, 09 Dec 2010 18:03:14 +0100 4243565 http://www.medworm.com/index.php?rid=4243567&cid=s_35775_34_f&fid=35775&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FBiohealthInvestor%2F%7E3%2FpmrfVHqjPR8%2Fobesity-player-raising-more-capital-etrm.html EnteroMedics Inc. (NASDAQ: ETRM) is raising more capital than had been previously disclosed and its shares are getting hit as a result.  The company which focuses on devices using neuroblocking technology now plans to sell more shares and warrants. The company is raising R&D funds for the commercialization of its obesity treatment. It is selling 14.8 million shares and warrants, higher than the 12 million previously disclosed.  The price is at $1.75, with a warrant exercise price of $2.19 per share. As far as how this compares to the float and dilution, that is rather large because the float was said to be only about 7.5 million shares before this offering. After the obesity treatment news from Orexigen (NASDAQ: OREX) this week, the hiked offering may be less of a surprise.  Here is... BioHealth Investor news http://www.medworm.com/rss/comments.php?id=4243567 Thu, 09 Dec 2010 13:46:20 +0100 4243567 http://www.medworm.com/index.php?rid=4239857&cid=s_35775_34_f&fid=35775&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FBiohealthInvestor%2F%7E3%2FiyI8f9Rm6qM%2Fanalyst-highlights-vivus-against-orexigen-orex-vvus.html Bank of America/Merrill Lynch is out with a very positive call for VIVUS, Inc. (NASDAQ: VVUS) after Orexigen Therapeutics, Inc. (NASDAQ: OREX) received an FDA panel backing yesterday for its Contrave diet pill for weight loss.  The thesis here is that the path for FDA approval of Qnexa for weight loss will also be set. BofA/ML raised its rating to BUY and more importantly it raised its price target objective to $12.00 from $6.00 in the call. The note says, “We previously had low expectations for a near-term approval for VIVUS’ obesity drug Qnexa, due to concerns that the FDA would require a large scale cardiovascular events trial prior to approval, consistent with the agency’s more cautious stance on CV risks for metabolic drugs. The FDA advisory panel’s vote for Orexigen&... BioHealth Investor news http://www.medworm.com/rss/comments.php?id=4239857 Wed, 08 Dec 2010 13:10:29 +0100 4239857 http://www.medworm.com/index.php?rid=4239858&cid=s_35775_34_f&fid=35775&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FBiohealthInvestor%2F%7E3%2FNnh81RWv-sY%2Fcontrave-panel-backing-new-love-for-diet-pills-orex-vvus-arna.html What?  An FDA panel backing in the diet pill arena?  Orexigen Therapeutics Inc. (NASDAQ: OREX) had seen some controversy grow around its Contrave diet drug pill to assist in weight loss, but tonight is good night at the company.  An FDA panel voted 13 YES to 7 NO in an advisory panel recommendation before a formal FDA review for approval.  If approved, this would mark the first real diet drug in a decade.  This news is likely to bolster rivals as well. Contrave was voted on favorably after its benefits in weight loss in the obese are greater than the risks.  Earlier comments voiced concern over heart risks. While the FDA formal approval or denial is not assured, the general trend is that the FDA follows a panel advisory recommendation when the votes are a large majority in favor of a... BioHealth Investor news http://www.medworm.com/rss/comments.php?id=4239858 Tue, 07 Dec 2010 21:46:26 +0100 4239858 http://www.medworm.com/index.php?rid=4235312&cid=s_35775_34_f&fid=35775&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FBiohealthInvestor%2F%7E3%2FEtSyu6DwCRI%2Ftop-biohealth-analyst-upgrades-downgrades-amgn-azn-bay-biib-celg-exam-gild-gsk-hgsi-lh-nvs-pfe-uthr-wcrx.html We have seen many research calls from Wall Street analysts with upgrades, downgrades, and initiations this Tuesday in the world of biotech, pharmaceuticals, and biohealth.  Some of the key calls we have seen are as follows: Amgen Inc. (NASDAQ: AMGN) Started as Neutral w/ $58 target at Credit Suisse. AstraZeneca (NYSE: AZN) Cut to Underperform at Credit Suisse. Bayer AG (NYSE: BAY) Raised to Outperform at Credit Suisse. Biogen Idec Inc. (NASDAQ: BIIB) Started as Neutral w/ $68 target at Credit Suisse. Celgene Corporation (NASDAQ: CELG) Started as Neutral w/ $60 target at Credit Suisse. Celgene Corporation (NASDAQ: CELG) Maintained Buy with $68 price target at BofA/ML. Examworks Group Inc. (NASDAQ: EXAM) Started as Outperform w/ $22 target at Credit Suisse. Gilead Sciences Inc. (NASDAQ: GIL... BioHealth Investor news http://www.medworm.com/rss/comments.php?id=4235312 Tue, 07 Dec 2010 13:29:28 +0100 4235312 http://www.medworm.com/index.php?rid=4235313&cid=s_35775_34_f&fid=35775&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FBiohealthInvestor%2F%7E3%2F9gn64XduRGA%2Fgeron-raising-fresh-capital-gern.html Geron Corporation (NASDAQ: GERN) is punishing its speculating stem cell investing shareholders in the after-hours session after the close on Monday.  The company has announced an offering of stock to raise capital.  That is bad for current holders in that it is dilutive, but it is good for the company as it is raising capital and all of the shares being sold are being sold by the company. No formal share size was offered up in the release for its underwritten public offering, but it did note that Geron also expects to grant the underwriters a 30-day option to purchase up to an additional 15% of the shares of common stock offered in the public offering to cover over-allotments. While shares are lower, the company did recently announce a move to Phase II in breast cancer studies.  That sh... BioHealth Investor news http://www.medworm.com/rss/comments.php?id=4235313 Mon, 06 Dec 2010 21:16:11 +0100 4235313 http://www.medworm.com/index.php?rid=4231729&cid=s_35775_34_f&fid=35775&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FBiohealthInvestor%2F%7E3%2F3Cv-aGmlj0k%2Fvivus-marches-on-in-erectile-dysfunction-vvus.html VIVUS, Inc. (NASDAQ: VVUS) is indicated higher on news after it announced positive results from is Phase III study of Avanafil or TA-314.  This is VIVUS’ investigational drug candidate for the treatment of erectile dysfunction. The company reported that this study met all primary endpoints with improvement from baseline in erectile function as measured by the Sexual Encounter Profile (both SEP2 and SEP3) and improvements in the International Index of Erectile Function (IIEF).  Patients treated with avanafil who attempted sexual intercourse (SEP3) within the first 15 minutes of dosing had success rates of 80%. The open label study was in over 700 enrolled patients using avanafil as needed and at a dose of their choosing.  The company noted that continues to anticipate the completio... BioHealth Investor news http://www.medworm.com/rss/comments.php?id=4231729 Mon, 06 Dec 2010 13:07:10 +0100 4231729 http://www.medworm.com/index.php?rid=4227415&cid=s_35775_34_f&fid=35775&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FBiohealthInvestor%2F%7E3%2Fo0OmdC4Mtps%2Ffda-brings-more-doubt-over-benlysta-against-lupus-hgsi-gsk.html More problems for those suffering from lupus!  The FDA has decided to delay its review of the proposed lupus treatment BENLYSTA.  Human Genome Sciences, Inc. (NASDAQ: HGSI) and GlaxoSmithKline PLC (NYSE: GSK) announced after the close of trading today that the FDA has extended the Prescription Drug User Fee Act target date for its priority review of the Biologics License Application (BLA) for BENLYSTA. The review extension just went from December 9, 2010 all the way out to March 10, 2011.  The companies noted, “After the FDA Arthritis Advisory Committee met on November 16, 2010 to consider the BENLYSTA BLA, the FDA requested some additional information from HGS, which has been submitted. BENLYSTA is an investigational drug and the first in a new class of drugs called BLyS-specific... BioHealth Investor news http://www.medworm.com/rss/comments.php?id=4227415 Fri, 03 Dec 2010 21:55:41 +0100 4227415 http://www.medworm.com/index.php?rid=4227416&cid=s_35775_34_f&fid=35775&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FBiohealthInvestor%2F%7E3%2FbUHUmyvYP5A%2Forexigens-turn-in-the-barrel-at-fda-on-diet-drug-orex-arna-vvus-abt.html As you have grown accustomed to, the FDA is hitting a company before its PDUFA date.  Orexigen Therapeutics, Inc. (NASDAQ: OREX) is under pressure after FDA briefing documents ahead of next Tuesday’s FDA panel meeting that is meant to recommend whether the FDA should or should not approve Orexigen’s diet drug called Contrave. Orexigen shares are down as FDA staff comments question whether or not the diet pill is safe and effective.  Contrave has reportedly satisfied only one of two efficacy measures in the FDA studies.  The safety profile is also under the microscope as Contrave has been linked to higher blood pressure, dizziness, psychiatric events and kidney dysfunction. The concerns here seem to be more legitimate concerns than others.  It also feels like it is just Orex... BioHealth Investor news http://www.medworm.com/rss/comments.php?id=4227416 Fri, 03 Dec 2010 14:43:34 +0100 4227416 http://www.medworm.com/index.php?rid=4222724&cid=s_35775_34_f&fid=35775&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FBiohealthInvestor%2F%7E3%2FRi3K_1y-jVk%2Fgeron-takes-breast-cancer-stem-cell-study-to-phase-ii-gern.html Geron Corporation (NASDAQ: GERN) is taking its breast cancer study with stem cells to Phase II.  The company announced this morning the enrollment of the first patient in a randomized Phase 2 clinical trial of its telomerase inhibitor drug, imetelstat (GRN163L), in combination with paclitaxel (with or without bevacizumab) in patients with locally recurrent or metastatic breast cancer. The Phase I program and preclinical data that showed imetelstat’s activity against cancer stem cells from a broad range of tumor types, including breast cancer.  The Phase I trial of imetelstat combined with paclitaxel and bevacizumab showed an encouraging preliminary response rate. The Phase II trial is an open label, multi-center, randomized study to measure safety and efficacy.  The primary efficacy e... BioHealth Investor news http://www.medworm.com/rss/comments.php?id=4222724 Thu, 02 Dec 2010 12:42:07 +0100 4222724 http://www.medworm.com/index.php?rid=4217154&cid=s_35775_34_f&fid=35775&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FBiohealthInvestor%2F%7E3%2F3fVfddiSKLg%2Fbofa-analyst-rallies-behind-dendreon-dndn.html Dendreon Corporation (NASDAQ: DNDN) is seeing shares gain this morning on news that Bank of America/Merrill Lynch initiated research coverage with a BUY rating and a $44 price target objective.   The buy rating was initiated with the belief that its PROVENGE will see significant market penetration after its manufacturing capacity expansion in 2011.  BofA called PROVENGE a first-in-class product and a product that will drive a biotechnology business model with unique manufacturing challenges.  Also noted was a high barrier to competitive entry. BofA/ML research noted, “We believe DNDN shares trade at a discount to future cash flow potential as the overhang of execution into a big launch year looms. While 2011 is not risk-free, we are encouraged by strong demand metrics, and believ... BioHealth Investor news http://www.medworm.com/rss/comments.php?id=4217154 Wed, 01 Dec 2010 13:33:37 +0100 4217154 http://www.medworm.com/index.php?rid=4217155&cid=s_35775_34_f&fid=35775&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FBiohealthInvestor%2F%7E3%2FkovRxxO3feM%2Fnew-hope-for-radiation-chemo-toxicity.html An FDA notice today seems to have gone almost entirely unnoticed.  This is something that  should have been a key stand-out event today in the world of cancer treatments even if some may have anticipated this development.  Cleveland BioLabs, Inc. (NASDAQ: CBLI) announced that its CBLB502 was granted Orphan Drug status by the FDA.  This is a drug under development to treat exposure to radiation for “prevention of death following a potentially lethal dose of total body irradiation during or after a radiation disaster.”  The indication is one thing.  The ramifications are another. Today’s Orphan Drug designation qualifies CBLB502 for an accelerated review process, as well as tax credits, financial assistance for development costs, and seven years of marketing exclusivi... BioHealth Investor news http://www.medworm.com/rss/comments.php?id=4217155 Tue, 30 Nov 2010 19:10:57 +0100 4217155 http://www.medworm.com/index.php?rid=4210537&cid=s_35775_34_f&fid=35775&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FBiohealthInvestor%2F%7E3%2Fn-L3_yEZ2kk%2Foutlook-2011-part-ii-2010-biohealth-winners-amrn-ilmn-inhx-jazz-nbix-npsp-thrx-vphm.html 2011 is getting closer and closer, and we wanted to review some of the standout BioHealth winners for 2010 to see what their  prospects are for 2011.  The rounds of exponential gains seen in 2009 were not repeated as frequently in 2010 for the severity  of gains. The FDA has been difficult to  predict in 2010 and many companies with high expectations managed to become flops which either saw denied FDA approval or were given severe delays.  We wanted to review the companies that are up more than 100% from their lows of the last 52-weeks to see which have prospects out into 2011 or beyond. Amarin Corporation plc (NASDAQ: AMRN), Illumina Inc. (NASDAQ: ILMN), Inhibitex Inc. (NASDAQ: INHX), Jazz Pharmaceuticals, Inc. (NASDAQ: JAZZ), Neurocrine Biosciences Inc. (NASDAQ: NBIX), NPS Pharmaceu... BioHealth Investor news http://www.medworm.com/rss/comments.php?id=4210537 Tue, 30 Nov 2010 15:56:54 +0100 4210537 http://www.medworm.com/index.php?rid=4210538&cid=s_35775_34_f&fid=35775&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FBiohealthInvestor%2F%7E3%2FXTHiQgzG7VM%2Fis-sangamo-buyout-bait-sgmo-lly.html Sangamo Biosciences Inc. (NASDAQ: SGMO) may not be the biggest name in the biotech world, but it is among the latest with buyout rumors driving its share price. Rumors of a potential bid interest from Eli Lilly & Co. (NYSE: LLY) drove shares higher all day on Monday.  The rumor is that the drug developer is being looked at by Lilly. The rumors may be tied to data from the last couple of weeks after it presented Phase II clinical data from its ZFP Therapeutic program to develop SB-509, a zinc finger protein transcriptional activator (ZFP-TF) of the vascular endothelial growth factor (VEGF)-A gene as a treatment for ALS. Its presentation data from study SB-509-801 demonstrated that the drug was well-tolerated in subjects with ALS and that 40% of SB-509 treated subjects had delayed deter... BioHealth Investor news http://www.medworm.com/rss/comments.php?id=4210538 Mon, 29 Nov 2010 21:23:15 +0100 4210538 http://www.medworm.com/index.php?rid=4210539&cid=s_35775_34_f&fid=35775&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FBiohealthInvestor%2F%7E3%2Fd3IavgcSUrs%2Foutlook-2011-2010-biohealth-winners-part-1-aria-chtp-cycc-enmd-exas-exel-fold-idix.html 2010 has so far lacked all of the juice that drove many biotech stocks exponentially higher in 2009.  For starters, the start of this year was not initiated with a deadly round of panic selling and followed by a major recovery in share prices with a hard V-bottom.  We have also had what feels like fewer FDA blockbuster approvals at the same time that many key drugs expected to be approved were either denied approval outright or were given severe delays.  We wanted to review the companies that are up more than 100% from their lows of the last 52-weeks to see which have prospects out into 2011 or beyond. Some of the key bioheath stand out names for 2010 are Ariad Pharmaceuticals Inc. (NASDAQ: ARIA), Chelsea Therapeutics International Ltd. (NASDAQ: CHTP), Cyclacel Pharmaceuticals, Inc. (NA... BioHealth Investor news http://www.medworm.com/rss/comments.php?id=4210539 Mon, 29 Nov 2010 19:15:21 +0100 4210539 http://www.medworm.com/index.php?rid=4204699&cid=s_35775_34_f&fid=35775&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FBiohealthInvestor%2F%7E3%2FmPe8252-lYQ%2Fmore-genzyme-ma-drama-genz-sny.html Genzyme Corporation (NASDAQ: GENZ) could be interpreted as cutting its own nose off just to spite its face if you have followed the merger and share price drama over the last few months.  While the company is trying to maximize shareholder value and perhaps hoping for rival bids above the $69 offer from Sanofi-Aventis (NYSE: SNY), the company is making noise again that may act to actually drive shares lower rather than higher as it hopes. Chief Executive Officer Henri Termeer has been quoted saying in an article in the French daily Le Figaro that Genzyme has a list of defenses to fend off the $69.00 cash buyout of Sanofi-Aventis.  Among these defenses named is the use of the “poison pill.”  The company has not made any formal decision there on that front, which is effectivel... BioHealth Investor news http://www.medworm.com/rss/comments.php?id=4204699 Fri, 26 Nov 2010 16:41:55 +0100 4204699 http://www.medworm.com/index.php?rid=4194057&cid=s_35775_34_f&fid=35775&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FBiohealthInvestor%2F%7E3%2FZ3B5hjLpLVI%2Fregenerons-long-term-prospects-become-much-more-positive-regn-bay.html Regeneron Pharmaceuticals Inc. (NASDAQ: REGN) is a big winner today on news of its Wet Age-related Macular Degeneration drug.  Bayer AG (NYSE: BAY) and Regeneron gave a report that top-line results of two Phase III studies with VEGF trap-eye in Wet Age-related Macular Degeneration were very positive.  The reports showed that in both studies all regimens of VEGF Trap-Eye achieved primary endpoint compared to ranibizumab dosed every month.  The companies noted that regulatory applications are planned in the first half of 2011 for marketing approval. Regeneron shares are running up on news that its experimental eye drug worked better than Roche’s Lucentis with fewer doses.  Today’s results are from the third and final stage of tests generally needed for U.S. approval.  If results... BioHealth Investor news http://www.medworm.com/rss/comments.php?id=4194057 Mon, 22 Nov 2010 16:23:48 +0100 4194057 http://www.medworm.com/index.php?rid=4187801&cid=s_35775_34_f&fid=35775&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FBiohealthInvestor%2F%7E3%2FtHgm0yQPC5U%2Fsomething-brewing-at-genzyme-ma-and-more-genz-sny-gsk.html Genzyme Corporation (NASDAQ: GENZ) may have some signs of life.  On what felt much like a directionless Friday, the biotechnology company under a turnaround and under an M&A tree may actually have some interest. The company rose Friday on news that it expects to meet the November 28, 2010 deadline to move the finishing and filling operations out of its Allston, Massachusetts plant for U.S. products. Genzyme has suffered as a result of a virus and contamination at its Allston plant, which is one of the key factors that bruised the stock over the last year before Sanofi-Aventis (NYSE: SNY) stepped in with a buyout offer. Reports were out this week that GlaxoSmithKline plc (NYSE: GSK) wasnit interested in making a competing bid for Genzyme. While a $1.00+ gain might not be out of the ord... BioHealth Investor news http://www.medworm.com/rss/comments.php?id=4187801 Sat, 20 Nov 2010 14:56:44 +0100 4187801 http://www.medworm.com/index.php?rid=4185115&cid=s_35775_34_f&fid=35775&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FBiohealthInvestor%2F%7E3%2FgNmHx3cCgTc%2Fmela-gets-new-signs-of-life-after-fda-panel-mela.html MELA Sciences Inc. (NASDAQ: MELA) turns out to not be as dead of an issue as its stock performance was indicating over the last week.  Unfortunately, there are caveats here. The company’s experimental skin cancer detection device called MELAFind won FDA panel backing.  The problem is that the vote was a mere 8 FOR versus 7 AGAINST. Some expressed concerns that the device actually works better than a traditional doctor screen.  Others believe that the device offers a new hope. Either way, the panel vote is a win for the company.  The device still has to face a formal FDA approval.  The computerized system aims to help dermatologists decide whether or not skin lesions need further biopsy to find melanoma. The FDA had brought up concerns and MELA shares hit skid row.  There are st... BioHealth Investor news http://www.medworm.com/rss/comments.php?id=4185115 Fri, 19 Nov 2010 13:27:11 +0100 4185115 http://www.medworm.com/index.php?rid=4180834&cid=s_35775_34_f&fid=35775&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FBiohealthInvestor%2F%7E3%2FLF6rLArpWHM%2Fdendreon-one-step-closer-to-provenge-approval-expansion-dndn.html Dendreon Corporation (NASDAQ: DNDN)  is seeing a surge this morning after its PROVENGE for prostate cancer received a positive vote from a Medicare coverage advisory panel late on Wednesday.  This had been a key hurdle, although the price has always been the issue even if the ‘efficacy’ issue was brought up. The news suggests that Medicare will pay more than $90,000 per patient for the treatment, and it is no secret that prostate cancer usually hits those who are already under Medicare. This is one more step rather than an ultimate and final conclusion.  This does seem to be an added win, as you would notice in teh share rally this morning. We are expecting a final ruling from Medicare late in the first quarter of 2011.  We also expect that coverage will be granted in at le... BioHealth Investor news http://www.medworm.com/rss/comments.php?id=4180834 Thu, 18 Nov 2010 14:50:02 +0100 4180834 http://www.medworm.com/index.php?rid=4173628&cid=s_35775_34_f&fid=35775&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FBiohealthInvestor%2F%7E3%2FNNOfgE4Glo8%2Fvindication-for-human-genome-takeover-chatter-to-resume-hgsi-gsk.html Human Genome Sciences Inc. (NASDAQ: HGSI) has some vindication for its BENLYSTA as a treatment for lupus.  The company announced that it and partner GlaxoSmithkline plc (NYSE: GSK) received FDA panel backing from the Arthritis Advisory Committee. The company noted that a vote tally of 13 approval recommendations was above the 2 that recommended against approval.  The FDA does not always follow its panel recommendations, but generally it does and a wide vote like this makes the winds favor an approval over a blockage.  If approved as a treatment for autoantibody-positive patients with active systemic lupus erythematosus, this would mark the first treatment in about two generations. The FDA’s committee is convened to provide the FDA with independent expert advice on a broad range of... BioHealth Investor news http://www.medworm.com/rss/comments.php?id=4173628 Tue, 16 Nov 2010 23:35:26 +0100 4173628 http://www.medworm.com/index.php?rid=4173629&cid=s_35775_34_f&fid=35775&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FBiohealthInvestor%2F%7E3%2FTEC-_0rtvxw%2Fmela-runs-into-fda-wall-mela.html Mela Sciences Inc. (NASDAQ: MELA) is living up ton one of the two double OR half scenarios outlined by Barron’s.  Unfortunately it is the bad side of the equation.  The FDA has told MELA that its formal panel review for MelaFind will be on Thursday. The FDA’s General and Plastic Surgery Devices Panel will review MELA’s Pre-Market Approval application on Thursday, November 18 at 8:00 AM EST and the advisory committee meeting will take place at the Holiday Inn College Park, Grand Ballroom, 10000 Baltimore Ave., College Park, MD. the stock is getting crushed because FDA officials have thrown out some rather harsh comments on MelaFind.  The FDA released documents that are almost shocking if you had not been watching the share price of the stock going into the review.  Tho... BioHealth Investor news http://www.medworm.com/rss/comments.php?id=4173629 Tue, 16 Nov 2010 14:49:23 +0100 4173629 http://www.medworm.com/index.php?rid=4163652&cid=s_35775_34_f&fid=35775&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FBiohealthInvestor%2F%7E3%2F-AV_uHnwKG8%2Fclearing-some-air-in-genzyme-hgsi-genz-hgsi.html Two key biotechs had a rough day on Friday and these issues will be key to focus on in the coming days.  Genzyme Corporation (NASDAQ: GENZ) is showing some very concerning trends, and the first Lupus drug in two generations from Human Genome Sciences Inc. (NYSE: HGSI) may now have some safety concerns.  We wanted to take a look at the action  in each and offer some outlook and color for further review. We have previous noted how and why Genzyme Corporation (NASDAQ: GENZ) may be the entire pivot point for the biotech sector in 2011.  We conducted an options analysis on Friday evening and have found not just that there was unusual options trading in the company.  The options trading reveals that traders are betting on a breakdown in the Sanofi-Aventis (NYSE: SNY) merger and/or that no n... BioHealth Investor news http://www.medworm.com/rss/comments.php?id=4163652 Sat, 13 Nov 2010 14:47:09 +0100 4163652 http://www.medworm.com/index.php?rid=4163653&cid=s_35775_34_f&fid=35775&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FBiohealthInvestor%2F%7E3%2FrYA3hdZSuCM%2Fmelas-skin-cancer-review-in-the-shade-mela.html MELA Sciences, Inc. (NASDAQ: MELA) was rather active on Friday.  While this is a device for detection of melanoma, this is often just as volatile as an emerging biotech company.  Shares closed down 5.7% on Friday and the volume was more than elevated: 1,983,330 shares versus an average volume of 556,070 shares.  The day’s range was $5.23 to $5.90 and more importantly its 52-week range is now $5.23 to $12.24. The stock is breaking down ahead of an FDA review next Tuesday.  The FDA is expected to post briefing documents on Tuesday for its advisory panel to review its melanoma detection device called MELAFind.  When stocks hit 52-week lows going into FDA events, this is always a red flag that investors need to take note of. It was back on Monday NOV. 1 that MELA shares fell more th... BioHealth Investor news http://www.medworm.com/rss/comments.php?id=4163653 Sat, 13 Nov 2010 14:25:42 +0100 4163653 http://www.medworm.com/index.php?rid=4153726&cid=s_35775_34_f&fid=35775&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FBiohealthInvestor%2F%7E3%2FVbCHCCDov8M%2F2011-biotech-sector-outlook-hinges-on-genzyme-deal-genz-biib-life-ilmn-dndn-hgsi-sny.html We have previously outlined how the bull market is leaving biotech in the dust.  With a lack of exponential growers in 2010 compared to 2009, there is a sad state of affairs that may be the most crucial element of all for biotech in 2011.  Genzyme Corporation (NASDAQ: GENZ) could be the one critical element for the whole biotech sector.  We would pay particular attention to Biogen Idec Inc. (NASDAQ: BIIB), Life Technologies Corporation (NASDAQ: LIFE), Illumina Inc. (NASDAQ: ILMN), Dendreon Corp. (NASDAQ: DNDN), and Human Genome Sciences Inc. (NASDAQ: HGSI), depending upon the outcome of the Genzyme situation. Genzyme shares have slid after the Sanofi-Aventis (NYSE: SNY) offering peak and the larger company has asked Genzyme to come to the bargaining table.  So far, Genzyme is looking f... BioHealth Investor news http://www.medworm.com/rss/comments.php?id=4153726 Wed, 10 Nov 2010 15:54:05 +0100 4153726 http://www.medworm.com/index.php?rid=4146714&cid=s_35775_34_f&fid=35775&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FBiohealthInvestor%2F%7E3%2FbLuplnNCb50%2Fa-call-for-a-stock-double-inhx.html Inhibitex Inc. (NASDAQ: INHX) may be slightly lower after earnings, but an analyst note is endorsing the long-term merits of the company.  Zacks Research’s Jason Napodano, CFA, announced that Zacks is recommending the purchase of Inhibitex (INHX) ahead of two major catalysts which are coming down the pipe in the next few months ahead. The research notes: In December 2010, management plans to release top-line data from the ongoing phase II program with FV-100.  The trial is designed to show FV-100 superiority to Glaxo’s Valtrex (valacyclovir) in the treatment of herpes zoster (shingles).  FV-100, has the potential to be a game changer for the treatment of shingles.  The current standard of care, valacyclovir, with an estimated 60% market share, is dosed at 1000mg three times a d... BioHealth Investor news http://www.medworm.com/rss/comments.php?id=4146714 Tue, 09 Nov 2010 19:54:06 +0100 4146714 http://www.medworm.com/index.php?rid=4141675&cid=s_35775_34_f&fid=35775&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FBiohealthInvestor%2F%7E3%2FsTxG5aB5HB0%2Fpost-qe2-economy-skipping-biotech-bbh-xbi-celg-gild-amgn-biib-alxn-mnkd-hgsi-vvus-dndn.html Things have changed in the last week.  The mid-term elections took away the majority of the House of Representatives, and the Senate now no longer has the super-majority which could get laws passed no matter what they included.  Now it seems that the tax cuts may be extended for another year or maybe two years, which could imply a permanent change ahead if the 2010 election trends remain close to the same in 2012.  Quantitative easing from the FOMC is meant to drive investors into riskier assets and create a higher pricing environment to avoid deflationary pressure.  Generally speaking, those riskier assets are commodities, and broader stocks tied to industrial, exports, financials, and more.  But what about biotech and emerging pharma?  So far, QE2, tax extension, and the reversal o... BioHealth Investor news http://www.medworm.com/rss/comments.php?id=4141675 Sat, 06 Nov 2010 13:41:40 +0100 4141675 http://www.medworm.com/index.php?rid=4136999&cid=s_35775_34_f&fid=35775&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FBiohealthInvestor%2F%7E3%2FjkArv7vqhKE%2Fgoldman-sachs-caution-in-biotechs-amgn-biib-celg-gild-alxn.html Goldman Sachs is taking a very cautious view on many of the large biotech leaders in a new coverage call.  While there is a silver lining call in one, the bulk of the research has a very cautious stance due to revenue woes that could lie ahead for the large biotechs. Amgen Inc. (NASDAQ: AMGN) started with a “SELL” rating. Biogen Idec Inc. (NASDAQ: BIIB) started with a “SELL” rating. Celgene Corporation (NASDAQ: CELG) started with a “NEUTRAL” rating. Gilead Sciences Inc. (NASDAQ: GILD) started with a “NEUTRAL” rating. Alexion Pharmaceuticals, Inc. (NASDAQ: ALXN) is the standout stock this morning and the exception to the rule.  Alexion shares were started on the CONVICTION BUY LIST and the stock is up 2% at $71.94 and close to challenging th... BioHealth Investor news http://www.medworm.com/rss/comments.php?id=4136999 Thu, 04 Nov 2010 13:14:25 +0100 4136999 http://www.medworm.com/index.php?rid=4123135&cid=s_35775_34_f&fid=35775&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FBiohealthInvestor%2F%7E3%2FyIBgT2TkkLI%2Fbiodel-faces-biotech-implosion-on-fda-crl-biod.html Biodel Inc. (NASDAQ: BIOD) is the latest biotech to feel the pain of FDA denial.  The company is seeings its shares crushed this morning after the FDA issued a Complete Response Letter, which means that an approval was denied. The FDA Complete Response Letter was for Linjeta as an injection for the treatment of type 1 and type 2 diabetes to improve glycemic control. What was disclosed is the the FDA has requested additional information, including comments related to clinical trials, as well as statistical analysis, chemistry, manufacturing, and on controls. The FDA stated that the type 1 trial analysis over efficacy was not sufficient for establishing conclusive evidence of efficacy. In the type 2 trial analysis, the FDA noted that non-inferiority was established in the complete populatio... BioHealth Investor news http://www.medworm.com/rss/comments.php?id=4123135 Mon, 01 Nov 2010 13:49:56 +0100 4123135 http://www.medworm.com/index.php?rid=4113302&cid=s_35775_34_f&fid=35775&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FBiohealthInvestor%2F%7E3%2FjtcQeVOh6t4%2Fvivus-loss-looks-like-a-win-vvus.html VIVUS, Inc. (NASDAQ: VVUS) is doomed.  That is what you would think if you just saw the FDA denial to approve Qnexa for weight loss.  Most of the headlines on financial aggregation sites are full of negative headlines…. FDA Nixes VIVUS’ Qnexa, FDA Rejects VIVIS ObesityDrug, VIVUS Fails to Win U.S. Approval; US rejects Highly-Anticipated Diet Drug… and on and on.  While the FDA did not approve Qnexa and has asked for more data, the underlying belief now appears to be that despite the headlines Qnexa WILL ultimately be able able to secure FDA approval. VIVIS received a Complete Response Letter from the FDA on its New Drug Application for the investigational new drug QNEXA Controlled-Release Capsules, with the communication that the NDA cannot be approved in its present f... BioHealth Investor news http://www.medworm.com/rss/comments.php?id=4113302 Fri, 29 Oct 2010 13:20:21 +0100 4113302 http://www.medworm.com/index.php?rid=4113303&cid=s_35775_34_f&fid=35775&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FBiohealthInvestor%2F%7E3%2FNKF1M937iAo%2Fbiogen-losing-dead-money-image-biib-eln-nvs.html Biotech earnings are seeing mixed reactions after the news so far.  Biogen Idec Inc. (NASDAQ: BIIB) has some very positive momentum behind it that may be changing how investors view the company.  The company was noted as a win by Zacks Investment Research this morning with references to Elan Corp. (NYSE: ELN) and Novartis (NYSE: NVS).  What is perhaps most interesting about Biogen Idec is that the stock is hitting 52-week highs today and the new 52-week trading range is $41.75 to $61.57.  If you go back further, Biogen is actually trading at a high not seen since the big slide in mid-2008.  Some investors and traders may now be hoping that today’s move represents a full breakout from a very long trading range. Zacks noted Biogen Idec as “Biogen Beats by a Wide Margin&#8221... BioHealth Investor news http://www.medworm.com/rss/comments.php?id=4113303 Wed, 27 Oct 2010 17:42:58 +0100 4113303 http://www.medworm.com/index.php?rid=4113304&cid=s_35775_34_f&fid=35775&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FBiohealthInvestor%2F%7E3%2Fy7TGJs5eWg0%2Fa-long-term-bullish-case-for-gilead-gild.html There have been some mixed results from biotech stock giants so far this earnings season.  In some cases, these actually mimic Big Pharma stocks, but that is still out for debate.  We have seen some research outlining some of the top biotech shares from Zacks Investment Research.  Gilead Sciences, Inc. (NASDAQ: GILD) was called its BULL OF THE DAY pick.  Unfortunately, shares are down 1% at $39.21 but that is not a call based upon a one-day reaction. Zacks notes the following: Gilead Sciences, Inc. (NASDAQ: GILD) third quarter 2010 earnings of $0.85 was well above the year-ago earnings of $0.74. The improved showing was mainly attributable to strong sales of antiviral products. Gilead, a leading player in the HIV segment, has continued to increase its patient base. We remain optimistic... BioHealth Investor news http://www.medworm.com/rss/comments.php?id=4113304 Wed, 27 Oct 2010 17:30:23 +0100 4113304 http://www.medworm.com/index.php?rid=4102734&cid=s_35775_34_f&fid=35775&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FBiohealthInvestor%2F%7E3%2F81WlO2dYyrY%2Fsavients-lack-of-alternatives-nearly-an-implosion-svnt.html Savient Pharmaceuticals, Inc. (NASDAQ: SVNT) felt like an implosion on Monday, although technically it was less than the 50% threshold we have for a true implosion.   Shares had been trying to hold their own after a $21.78 open versus a $21.70 close on Friday.  The company announced today that its review on strategic alternatives failed to yield anything positive. The company said that its previously announced process to identify a buyer failed following the approval of KRYSTEXXA™ by the FDA. The board of directors also noted that the company will continue to evaluate its strategic alternatives available to maximize the value for shareholders. As a result, Savient said that it is working toward the commercial launch of KRYSTEXXA.  The company gave a date expected as “available ... BioHealth Investor news http://www.medworm.com/rss/comments.php?id=4102734 Mon, 25 Oct 2010 19:33:46 +0100 4102734 http://www.medworm.com/index.php?rid=4092482&cid=s_35775_34_f&fid=35775&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FBiohealthInvestor%2F%7E3%2FR8p7shhdGGk%2Fviropharma-hits-fda-snag-vphm.html ViroPharma Incorporated (NASDAQ: VPHM) shares were halted this morning after the FDA issued a complete response letter to the company.  The complete response letter is regarding Cinryze™, the company’s C1 Esterase Inhibitor, industrial scale manufacturing expansion activities. The problem with complete response letters is that it generally translates to delays.  That appears to be the case here at ViroPharma.  The company gave few details but noted that the FDA has requested additional information related to observations from the pre-approval inspection and review of the technical processes. The company said that it and partner Sanquin will begin working immediately to respond to the FDA “as expeditiously as possible.”  The company also noted that it plans to commen... BioHealth Investor news http://www.medworm.com/rss/comments.php?id=4092482 Fri, 22 Oct 2010 13:05:06 +0100 4092482 http://www.medworm.com/index.php?rid=4083975&cid=s_35775_34_f&fid=35775&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FBiohealthInvestor%2F%7E3%2FK1Y6mzjwfpQ%2Famylin-back-to-drawing-table-via-fda-denial-amln-alks-lly.html Amylin Pharmaceuticals Inc. (NASDAQ: AMLN) is getting pounded this morning.  Shares are effectively cut in half after the FDA declined to approve Bydureon as a potential diabetes drug with the request that it and partners need to do more testing.. The FDA requested a thorough QT study to analyze the effect on heart rates.  Also requested was the evaluation of the efficacy and the labeling of the safety and effectiveness. Eli Lilly & Co. (NYSEL LLY) and Alkermes Inc. (NASDAQ: ALKS) plan to respond to the FDA request, however the release said “by the end of next year” and that this was pending FDA discussions.  The requirement for this additional data will requiring a six month review. Amlylin’s Bydureon is the once a week injectable treatment of Byetta. Amylin also ... BioHealth Investor news http://www.medworm.com/rss/comments.php?id=4083975 Wed, 20 Oct 2010 12:21:24 +0100 4083975 http://www.medworm.com/index.php?rid=4063366&cid=s_35775_34_f&fid=35775&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FBiohealthInvestor%2F%7E3%2FdfI7MxW8_x4%2Falkermes-struggles-with-valuation-versus-fda-approval-alks.html Alkermes, Inc. (NASDAQ: ALKS) is trading higher on news that the FDA granted the company a wider approval of Vivitrol for treatment of opioid addiction.  The drug is already on the market for use in alcoholism, but unfortunately that is a low sales figure. Alkermes had projected the alcohol sales would be what we noted as $25 to $30 million in fiscal 2011.  Obviously the opioid addiction market opens this up to a market that has close to $1 billion in total sales in combined drug sales from the companies that treat this area.  That in turn can add significantly to prior targets. An approval was expected here for the drug, although predicting FDA outcomes has been more hope and guesswork than science of late.  The market cap of he company is already $1.5 billion, and Alkermes is project... BioHealth Investor news http://www.medworm.com/rss/comments.php?id=4063366 Wed, 13 Oct 2010 13:26:10 +0100 4063366 http://www.medworm.com/index.php?rid=4058175&cid=s_35775_34_f&fid=35775&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FBiohealthInvestor%2F%7E3%2FSP9-7bFnomQ%2Fimplosion-visits-in-alexza-alxa.html Alexza Pharmaceuticals Inc. (NASDAQ: ALXA) is witnessing a share implosion today with the loss of more than half its value.  The company was awaiting key data from the FDA and it turned out to be very unfavorable.  The FDA declined approving its AZ-004 drug candidate that was targeted to treat agitation in patients with schizophrenia and/or bipolar disorder. The FDA cited safety concerns as study data showed adverse respiratory reactions to the drug in some cases.  Alexza said in response that the company plans to meet with the FDA to address the agency’s safety concerns and it took the stance that it continues to believe in the safety and efficacy of the drug where there exists a large often-unmet need of treatment options. A complete response letter is issued by the FDA indicati... BioHealth Investor news http://www.medworm.com/rss/comments.php?id=4058175 Mon, 11 Oct 2010 16:04:35 +0100 4058175 http://www.medworm.com/index.php?rid=4058176&cid=s_35775_34_f&fid=35775&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FBiohealthInvestor%2F%7E3%2FINQtAEIB7NI%2Fimmunogen-continues-cancer-surge-imgn-nvs.html Immunogen Inc. (NASDAQ: IMGN) reported its positive study data this morning.  It also gave updated guidance where it sees a loss of $60 to $64 million for Fical-2011.  The company will co-produce cancer drugs with Novartis (NYSE: NVS). On the guidance: ” Net cash used in operations is expected to be between $0 and $4 million, with a net loss expected to total between $60 and $64 million. Cash and marketable securities at its fiscal year end of June 30, 2011 are expected to total between $106 and $110 million, which should be sufficient to fund operations through the Company’s 2013 fiscal year.” The early-stage data evaluating lorvotuzumab mertansine in CD56+ solid tumors showed patients with any type of CD56+ solid tumor were eligible for enrollment. In the ongoing expansio... BioHealth Investor news http://www.medworm.com/rss/comments.php?id=4058176 Mon, 11 Oct 2010 15:33:50 +0100 4058176 http://www.medworm.com/index.php?rid=4042846&cid=s_35775_34_f&fid=35775&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FBiohealthInvestor%2F%7E3%2FZQNQlN8284w%2Fpromising-data-in-new-breast-cancer-treatment-candidate-imgn.html Immunogen Inc. (NASDAQ: IMGN) is seeing a substantial move today on word of TDM-1 under development by Roche and ImmunoGen posted higher response rates and also showed lower toxicity than the blockbuster breast cancer drug Herceptin. The study is in 137 women with metastatic breast cancer who had no prior chemotherapy.  The study was also randomized to treatment with TDM-1 or Herceptin plus the chemotherapy drug Taxotere.  Also noted was that the response rate in patients treated with TDM-1 was 48% compared to a 41% response rate in patients that were treated with Herceptin and Taxotere. This is from results from the first head-to-head study of these two drugs that will be presented at a cancer meeting in Europe on Monday.  The data in breast cancer patients is still very early and very... BioHealth Investor news http://www.medworm.com/rss/comments.php?id=4042846 Fri, 08 Oct 2010 17:00:43 +0100 4042846 http://www.medworm.com/index.php?rid=4042847&cid=s_35775_34_f&fid=35775&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FBiohealthInvestor%2F%7E3%2Fke7yf147gpg%2Fmore-big-problems-for-obesity-drugs-abt-vvus-arna-orex.html Abbott Laboratories (NYSE: ABT) is the latest casualty in the war on obesity.  The company agreed this afternoon to voluntarily withdraw its obesity drug Meridia from the U.S. market.  Obesity drugs are just scorned by the FDA as side effects are being put ahead of the key benefits.  We are watching shares of VIVUS, Inc. (NASDAQ: VVUS), Arena Pharmaceuticals, Inc. (NASDAQ: ARNA), and Orexigen Therapeutics, Inc. (NASDAQ: OREX) as obesity-related secondary names. The reason: clinical trial data indicated an increased risk of heart attack and stroke, according to the FDA.  Here is the problem though.  The FDA approved Meridia all the way back in November 1997.  The approval was given for weight loss and maintenance of weight loss in obese people.  The problem is that the FDA also appro... BioHealth Investor news http://www.medworm.com/rss/comments.php?id=4042847 Fri, 08 Oct 2010 16:41:10 +0100 4042847 http://www.medworm.com/index.php?rid=4042848&cid=s_35775_34_f&fid=35775&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FBiohealthInvestor%2F%7E3%2FrbXyvRfwyp4%2Fonyx-faces-fda-delay-music-onxx.html Onyx Pharmaceuticals, Inc. (NASDAQ: ONXX) is delaying its New Drug Application filing with the FDA for carfilzomib.  The delay is based on a recent meeting with the FDA’s Chemistry, Manufacturing and Controls review division where it requested additional information related to commercial-scale manufacturing of carfilzomib. The company had previously expected to make its application by the end of this year for accelerated approval of carfilzomib.  The new target date for its NDA filing for accelerated FDA approval “could occur as early as mid-year 2011.”  In short, this is a half-year delay by the sound of it.  Maybe more. While trying to lessen fears, Onyx noted that the clinical profile of carfilzomib has not changed and it further noted that no new safety signals ha... BioHealth Investor news http://www.medworm.com/rss/comments.php?id=4042848 Thu, 07 Oct 2010 21:05:07 +0100 4042848 http://www.medworm.com/index.php?rid=4034094&cid=s_35775_34_f&fid=35775&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FBiohealthInvestor%2F%7E3%2FXOVh9mWB-CE%2Ffda-warning-letter-heads-to-gilead-genz-gild.html Everyone is familiar with the manufacturing woes of Genzyme Corporation (NASDAQ: GENZ) that helped lead to its poor share performance before Sanofi-Aventis decided to make an acquisition offer for the company.  There is a new FDA warning, this heading to Gilead Sciences Inc. (NASDAQ: GILD). The FDA has warned Gilead about quality control violations at one of the company facilities that is located out in California.  While Gilead had disclosed this, a FDA warning letter was posted with several problems discovered by regulators and inspectors at the San Dimas facility. Gilead was flagged for not having written procedures to help prevent bacterial contamination and it was also noted that Gilead failed on multiple occasions to investigate when batches of its pills failed on visual inspection... BioHealth Investor news http://www.medworm.com/rss/comments.php?id=4034094 Tue, 05 Oct 2010 19:35:02 +0100 4034094 http://www.medworm.com/index.php?rid=4029327&cid=s_35775_34_f&fid=35775&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FBiohealthInvestor%2F%7E3%2F21zFIWNWw_4%2Fvivus-peters-out-on-muse-for-erectile-dysfunction-vvus-pfe-lly.html When you hear the term ‘erectile dysfunction’ tied to the world of drugs and pharmaceuticals, chances are that the drugs that come to mind are VIAGRA and CIALIS.  After all, Pfizer Inc. (NYSE: PFE) and Eli Lilly & Co. (NYSE: LLY) have spent billions combined and had untold efforts getting those ED drugs to be your first choice.  VIAGRA broke records, then came ‘the weekender’ in Cialis. But there is a second tier of ED treatments that never really caught on in the same manner.  VIVUS, Inc. (NASDAQ: VVUS) has had its MUSE treatment on the market since 1997 and it has decided to sell off MUSE. The company has entered into an asset purchase agreement with Meda for MUSE where Meda will acquire the MUSE assets (including the United States and foreign MUSE patents,... BioHealth Investor news http://www.medworm.com/rss/comments.php?id=4029327 Mon, 04 Oct 2010 14:40:47 +0100 4029327 http://www.medworm.com/index.php?rid=4020604&cid=s_35775_34_f&fid=35775&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FBiohealthInvestor%2F%7E3%2FCs0ZvVPgXu8%2Fstandout-options-trading-in-amgen-amgn-teva.html Amgen Inc. (NASDAQ: AMGN) has seen some unusual options trading and it appears to be based around some upcoming FDA events and on its trends. Joe Kunkle  of OptionsHawk.com noted, “The January $52.50/$47.50 ratio put spread for 3,500X7,000 at $0.95 was an opening trade on September 30 after checking the open interest, and a bearish one with shares at $55.20.  Shares of the Biotech giant trade 10.22X earnings, 3.5X sales, and 9.2X cash flow, but have generally underperformed despite the valuation, and have now rallied more than 8% off lows to resistance at $56.50, already rolling over below the 200 day EMA.” We recently noted how the upcoming reviews could offer Amgen a “Genetech-like Drug Arsenal” if the approvals were met and if the tests go positive. Kunkle also... BioHealth Investor news http://www.medworm.com/rss/comments.php?id=4020604 Fri, 01 Oct 2010 12:13:08 +0100 4020604 http://www.medworm.com/index.php?rid=4015984&cid=s_35775_34_f&fid=35775&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FBiohealthInvestor%2F%7E3%2FppLtRqUAeSg%2Fhow-much-could-mannkind-fetch-mnkd-lly-nvo-pfe.html MannKind Corporation (NASDAQ: MNKD) is not without controversy. So what happens when you hear ‘buyout rumors’ driving the stock higher? Barron’s reported a rumor first being published by TheFlyOnTheWall that MannKind could be a takeout buyout candidate.  Eli Lilly & Co. (NYSE: LLY) was noted as the buyer, and $12.50 was the price hinted at. The problem is that it is still an outstanding issue over whether or not MannKind will get its inhaled insulin approved by the FDA.  The company has raised money and it has even gone as far as changing the name for AFREZZA. To make matters even more complicated, MannKind is a highly-shorted stock.  The most recent settlement date of September 15, 2010 showed that the short interest was down to 14.215 million shares.  That was a... BioHealth Investor news http://www.medworm.com/rss/comments.php?id=4015984 Wed, 29 Sep 2010 19:30:54 +0100 4015984 http://www.medworm.com/index.php?rid=4015985&cid=s_35775_34_f&fid=35775&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FBiohealthInvestor%2F%7E3%2F3ar07axI258%2Fdoes-amgen-have-a-genentech-like-cancer-arsenal-amgn-mrk-rhby-dndn.html Amgen Inc. (NASDAQ: AMGN) may have a recent trading history of being dead money.  There is at least a small chance that this could finally change through time.  If the implications end up coming to fruition, Amgen could be sitting on perhaps what could be the next Avastin-like franchise. Two recent pre-clinical mice studies show that the osteoporosis drug Prolia from Amgen may actually treat breast cancer in a manner that is separate from its bone-related function.  While you will hear “may” and “could” a lot, this is something to watch for Amgen due to a long-standing range bound stock price. Bisphosphonates as a class, from Merck & Co. (NYSE: MRK) with Fosamax and even from Roche Holding AG (RHHBY) with Boniva, could reduce the risk of breast cancer. Prolia... BioHealth Investor news http://www.medworm.com/rss/comments.php?id=4015985 Wed, 29 Sep 2010 18:34:25 +0100 4015985 http://www.medworm.com/index.php?rid=3985353&cid=s_35775_34_f&fid=35775&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FBiohealthInvestor%2F%7E3%2FYuH2y5JacME%2Fbiodel-seeks-fda-approval-for-diabetes-treatment.html Biodel Inc. (NASDAQ: BIOD) is up $0.68 (13.63%) today to $5.67 in anticipation of the October 30th FDA decision on whether or not to approve VIAject, the company’s diabetes treatment. Biodel Inc. is a biopharma company that works primarily in the treatment of diabetes. -Michael B. Sauter (Source: BioHealth Investor) BioHealth Investor news http://www.medworm.com/rss/comments.php?id=3985353 Mon, 20 Sep 2010 15:27:12 +0100 3985353 http://www.medworm.com/index.php?rid=3971174&cid=s_35775_34_f&fid=35775&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FBiohealthInvestor%2F%7E3%2F21qnsCT_km0%2Fneurocrine-depressed-over-major-depressive-disorder-nbix-gsk.html Neurocrine Biosciences, Inc. (NASDAQ: NBIX) just got a black eye.  The company announced on Tuesday evening that its potential treatment for major depressive disorder was ineffective in a mid-stage study. The study on GSK561679, conducted with GlaxoSmithKline (NYSE: GSK), involved 150 patients and was lined up against and compared with a placebo. This won’t make much difference now, but Neurocrine plans to hold a meeting with GlaxoSmithkline in the coming months after the full clinical data is avaialble and is reviewed.  Then it will discuss the next steps for the program.  Unfortunately, when drug trials are ineffective the next steps usually involve a handshake and a walking away. The company further noted that CRF1 remains a difficult drug target for depression. Shares closed a... BioHealth Investor news http://www.medworm.com/rss/comments.php?id=3971174 Wed, 15 Sep 2010 12:08:52 +0100 3971174 http://www.medworm.com/index.php?rid=3967417&cid=s_35775_34_f&fid=35775&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FBiohealthInvestor%2F%7E3%2Fnpb6kXzaUQ0%2Fcell-therapeutics-fights-for-pixantrones-survival-ctic.html Cell Therapeutics, Inc.(NASDAQ: CTIC) intends to appeal an FDA’s previously disclosed decision regarding the pixantrone New Drug Application to treat patients with relapsed/refractory aggressive non-Hodgkin’s lymphoma. CTI expects the FDA decision on the appeal in the fourth quarter of 2010. The company said in a release that it had requested accelerated approval of its new drug application for this patient group for which there are no currently approved drugs.  The FDA issued a Complete Response Letter to CTI related to this NDA stating, in part, that CTI should conduct an additional clinical trial prior to approval. CTI is preparing to file an appeal under the FDA’s Formal Dispute Resolution process and it reached this decision by taking into account that CTI believes ... BioHealth Investor news http://www.medworm.com/rss/comments.php?id=3967417 Tue, 14 Sep 2010 11:59:46 +0100 3967417 http://www.medworm.com/index.php?rid=3963848&cid=s_35775_34_f&fid=35775&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FBiohealthInvestor%2F%7E3%2FM9EFL5GROgg%2Fcyclacel-up-more-than-20.html BioCyclacel Pharmaceuticals, Inc. (NASDAQ: CYCC) has successfully negotiated a trial structure with the FDA for their experimental leukemia drug. Shares of CYCC are up %12.1 to $1.76, with most of the movement coming premarket. The stock has traded far above its average volume of 427 thousand, with 2.19 million shares traded today already. CYCC is trading in the middle of its 52-week range of $0.78-$4.08. -Michael B. Sauter (Source: BioHealth Investor) BioHealth Investor news http://www.medworm.com/rss/comments.php?id=3963848 Mon, 13 Sep 2010 15:54:57 +0100 3963848 http://www.medworm.com/index.php?rid=3963849&cid=s_35775_34_f&fid=35775&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FBiohealthInvestor%2F%7E3%2Fl7YT-6NxFqU%2Fsynta-expands-trial-of-new-drug.html Synta Pharmaceuticals Corp. (NASDAQ: SNTA) was up $0.41 (12.93%) to $3.58 on news that the company is expanding its Phase 2 clinical trial of STA-9090 for patients with non-small cell lung cancer from 69 to 146 patients.  The expansion is the result of positive results observed during the first stage of the two stage clinical trial. Synta is a biopharma company creates and sells drugs used for patients with diseases such as cancer and chronic inflammatory diseases. -Michael B. Sauter (Source: BioHealth Investor) BioHealth Investor news http://www.medworm.com/rss/comments.php?id=3963849 Mon, 13 Sep 2010 15:41:48 +0100 3963849 http://www.medworm.com/index.php?rid=3963850&cid=s_35775_34_f&fid=35775&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FBiohealthInvestor%2F%7E3%2F09Z-irnbIk0%2Fnovartis-meningitis-vaccine-performing-well-in-late-stage-trials.html According to Bloomberg, Novartis AG (NVS) recently reported that phase III trials of their Meningitis B vaccine were meeting its goals. While many forms of the disease are preventable, this vaccine is aimed at treating infants, who are particularly susceptible, and to whom the disease is most lethal. Shares of NVS are up .41% on moderate volume. -Michael B. Sauter (Source: BioHealth Investor) BioHealth Investor news http://www.medworm.com/rss/comments.php?id=3963850 Mon, 13 Sep 2010 15:34:21 +0100 3963850 http://www.medworm.com/index.php?rid=3963851&cid=s_35775_34_f&fid=35775&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FBiohealthInvestor%2F%7E3%2FO37rcP4hCDE%2Frelypsa-rounds-70m-for-lead-program.html Relypsa, a biopharma company created by several former Ilypsa executives after that company was purchased by biotech Amgen Inc. (NASDAQ: AMGN), has collected $70 million for its Series B.  The venture is now backed by a total of over $100 million. The company was formed on the rights to four preclinical programs acquired before the Amgen acquisition of Ilypsa, lead by RLY5016, a compound which now has the resources to go through necessary clinical trials, thanks to the latest round of money. RLY5016 is described by the company as a “high capacity non-absorbed oral potassium binder being developed for the chronic and acute management of hyperkalemia, which is most prevalent in patients that suffer from renal impairment, hypertension, diabetes and heart failure.” -Michael B. Sau... BioHealth Investor news http://www.medworm.com/rss/comments.php?id=3963851 Mon, 13 Sep 2010 15:07:45 +0100 3963851 http://www.medworm.com/index.php?rid=3963852&cid=s_35775_34_f&fid=35775&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FBiohealthInvestor%2F%7E3%2FV1o5Uyn8LnA%2Fgood-news-on-thyroid-cancer-war-oxgn.html OXiGENE, Inc. (NASDAQ: OXGN) is surging on news that it showed positive results from a randomized, controlled, Phase II/III study of ZYBRESTAT at the 14th International Thyroid Congress in Paris for its Anaplastic Thyroid Cancer treatment. The results were presented by Rossella Elisei, M.D., of the University of Pisa. In this 80-patient study, the median overall survival time was 5.1 months for patients who received ZYBRESTAT and chemotherapy when compared with a median survival time of 4.1 months for patients receiving chemotherapy alone (Hazard Ratio 0.71).  This represents a 29% reduction in the risk of dying for patients receiving ZYBRESTAT and chemotherapy. Of patients treated with ZYBRESTAT and chemotherapy, 48% were alive at six months, compared with 37% percent of patients treated... BioHealth Investor news http://www.medworm.com/rss/comments.php?id=3963852 Mon, 13 Sep 2010 12:42:33 +0100 3963852 http://www.medworm.com/index.php?rid=3963853&cid=s_35775_34_f&fid=35775&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FBiohealthInvestor%2F%7E3%2FMUxsqdF4Gng%2Fgenzyme-ma-defense-sell-off-pieces-genz-sny-lh.html Genzyme Corporation (NASDAQ: GENZ) is pursuing an interesting and outright dangerous strategy in its ongoing merger offer saga from Sanofi-Aventis (NYSE: SNY).  The company (Genzyme) and Laboratory Corp. of America Holdings (NYSE: LH) have entered into an asset purchase agreement where Laboratory Corporation will acquire Genzyme Genetics for $925 million in cash. LabCorp will purchase the business in its entirety and this sale includes testing services, technology, intellectual property rights, and its nine testing laboratories. LabCorp claims that it will offer employment to all 1900 employees, including senior management, of the unit.  The goal is to close the deal before the end of the year with appropriate regulatory approvals. Genzyme CEO Henri Termeer noted, “… shows how ou... BioHealth Investor news http://www.medworm.com/rss/comments.php?id=3963853 Mon, 13 Sep 2010 12:26:55 +0100 3963853 http://www.medworm.com/index.php?rid=3956307&cid=s_35775_34_f&fid=35775&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FBiohealthInvestor%2F%7E3%2FS3tx5Ad8xIc%2Fis-allos-really-a-buyout-candidate-alth-vphm-gern-pcyc.html What is the oldest trick in the book when you need a share price up after it challenges 52-week lows?  Float a a takeover rumor… Allos Therapeutics, Inc. (NASDAQ: ALTH) is up big on more than triple-normal the trading volume.   A fresh article from FORBES got the rumor going that Allos could be a takeover stock based upon a screen from biotechnology analyst Geoffrey Porges of Sanford C. Bernstein.  The claim is that 10,000 companies were screened to find a list of 25 that look like possible takeout candidates, and then Porges picked 4 of those which he thinks could get scooped up. On Allos, Porges noted that it sells the cancer drug Folotyn.  While the stock has not performed well ( big understatement), the ultra-orphan cancer niche would give a new team something that would app... BioHealth Investor news http://www.medworm.com/rss/comments.php?id=3956307 Fri, 10 Sep 2010 18:40:53 +0100 3956307 http://www.medworm.com/index.php?rid=3956309&cid=s_35775_34_f&fid=35775&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FBiohealthInvestor%2F%7E3%2FJwsey9GojFI%2Fk-v-comes-back-from-the-deep-kv-a-kv-b.html K-V Pharmaceutical Co. (NYSE: KV-A, NYSE: KV-B) is seeing a surge of trading interest after the company has now received FDA approval to return its first product to market after a successful inspection of its facilities last month. This move clears K-V to begin manufacturing and marketing two versions of its Micro-K potassium supplement.  The timing here is what matters because the company had not really expected to ship any product before the end of the current quarter. Unfortunately, this was not the first regulatory and compliance issues faced by the company.  K-V had previously stopped manufacturing and shipping all of its products back in early 2009.  Most products had even been recalled, including Toprol.  The company had to deal with an FDA investigation into its compliance matt... BioHealth Investor news http://www.medworm.com/rss/comments.php?id=3956309 Fri, 10 Sep 2010 13:34:02 +0100 3956309 http://www.medworm.com/index.php?rid=3949014&cid=s_35775_34_f&fid=35775&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FBiohealthInvestor%2F%7E3%2Fcw6bpNCjTtk%2Fpharma-biotech-major-research-alerts-teva-amgn-acor-celg-hgsi-biib-gild-exas-zgen-dyax-idxx-vphm.html Biotech and pharma research calls from Wall Street research firms have come out of the wood work this Thursday. Teva Pharmaceutical Industries Limited (NASDAQ: TEVA) is one of our recent “Defensive Stocks for the Next Bear Market” picks based upon valuation.  This morning Oppenheimer raised the rating to OUTPERFORM on hope and expectations that it will see a big boost in the second half from its Effexor sales. STIFEL NICOLAUS started many key biotech stocks with coverage this morning: Amgen Inc. (NASDAQ: AMGN) and Acorda Therapeutics, Inc. (NASDAQ: ACOR) and Celgene Corporation (NASDAQ: CELG) and Human Genome Sciences Inc. (NASDAQ: HGSI) were all started with BUY ratings; Biogen Idec Inc. (NASDAQ: BIIB) at SELL; Gilead Sciences Inc. (NASDAQ: GILD) at HOLD. EXACT Sciences Cor... BioHealth Investor news http://www.medworm.com/rss/comments.php?id=3949014 Thu, 09 Sep 2010 16:45:08 +0100 3949014 http://www.medworm.com/index.php?rid=3949015&cid=s_35775_34_f&fid=35775&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FBiohealthInvestor%2F%7E3%2F-UUfUX8qL88%2Fstem-cells-coming-back-from-brink-of-funding-bans-gern-stem-astm-cytx-nbs-isco-btim.html The Department of Justice, the White House, and many other activists have been steadily trading to get the ban lifted on the stem cell funding that surprised the entire biotech, drug, and stem cell research community.  Now it seems that a U.S. District Court has suspended that ban on state-funded embryonic stem cell research. Geron Corporation (NASDAQ: GERN) is now up 9% at $5.34 versus a 52-week trading range of $4.37 to $7.51.  Geron recently received an FDA lifting of a clinical trial hold involving spinal cord injuries. StemCells Inc. (NASDAQ: STEM) is up 7% at $0.83 versus a 52-week range of $0.75 to $1.79.  This one recently had positive paralysis study data and our indications were that much or all of the operations here were not really going to be hurt or hit from the funding ba... BioHealth Investor news http://www.medworm.com/rss/comments.php?id=3949015 Thu, 09 Sep 2010 16:15:07 +0100 3949015 http://www.medworm.com/index.php?rid=3949016&cid=s_35775_34_f&fid=35775&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FBiohealthInvestor%2F%7E3%2Fac2ABrQIeJs%2Fgenzymes-coming-time-press-on-merger-offer-genz-sny.html Genzyme Corporation (NASDAQ: GENZ) is getting close enough in the head on trucker game of chicken that either Sanofi-Aventis (NYSE: SNY) is going to flinch or Henri Termeer and the board of Genzyme need to flinch.  It just seems that there are not any of the other buyers out there.  Maybe it is the manufacturing woes, maybe it is that the cause of the virus was unknown or not fully explained, and maybe it is just that Termeer and others can recall a $80.00 share price before things went south. If Genzyme lets this bid from Sanofi-Aventis get away and if it the woes allowed competitors to up their own sales very much, Henri Termeer could face a black mark on what could be the crest of a great career as he took this company from the ground up.  Being the early-on CEO does not mean he is t... BioHealth Investor news http://www.medworm.com/rss/comments.php?id=3949016 Thu, 09 Sep 2010 16:02:50 +0100 3949016 http://www.medworm.com/index.php?rid=3944655&cid=s_35775_34_f&fid=35775&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FBiohealthInvestor%2F%7E3%2FHtklaa-tbNA%2Fquestor-meets-fda-snag-qcor.html Questcor Pharmaceuticals, Inc. (NASDAQ: QCOR) was a mere 48 hours away from an FDA drug decision for the review of Questcor’s supplemental new drug application for H.P. Acthar® Gel in the treatment of infantile spasms.  The key work now is “WAS” in the reference. The FDA just today informed Questcor that it requires additional time beyond the current action date of September 11, 2010.  During the supplemental new drug application review period, Questcor and the FDA have been updating and modernizing the product label for Acthar, which has not been modified since 1978, when multiple sclerosis was added to the label.  This step of the review process is now complete. Questcor has been notified that the FDA needs some additional time to finalize the wording on the label, ... BioHealth Investor news http://www.medworm.com/rss/comments.php?id=3944655 Wed, 08 Sep 2010 21:06:34 +0100 3944655 http://www.medworm.com/index.php?rid=3944656&cid=s_35775_34_f&fid=35775&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FBiohealthInvestor%2F%7E3%2FKIv08QsBjHk%2Frenhuang-pharmaceuticals-up-on-little-news.html Renhuang Pharmaceuticals (AMEX: CPB), a Chinese Company which hired a new CFO late last month, has gained nearly 20% in trading, on no discernible news.  As of 9:30 this morning, CBP was up 18.89% to $1.83 on very low volume. The stock is trading within a 52-week range of $0.50-$3.00. Renhuang is a pharmaceutical company which operates primarily in China and sells a variety of drugs designed to treat, among others neurological and heart disorders. -Michael B. Sauter (Source: BioHealth Investor) BioHealth Investor news http://www.medworm.com/rss/comments.php?id=3944656 Wed, 08 Sep 2010 16:46:46 +0100 3944656 http://www.medworm.com/index.php?rid=3944657&cid=s_35775_34_f&fid=35775&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FBiohealthInvestor%2F%7E3%2F7lqtfVWclbY%2Fzymogenetics-skyrockets-on-bristol-meyers-buyout.html ZymoGenetics, Inc. (NASDAQ: ZGEN) is up $4.45 (83.87%) today to $9.74 on news that Bristol-Myers Squibb Co. will be buying the company for $885 million, or $9.75 per share. ZymoGenetics is a biopharma company that specializes in the development and production on therapeutic proteins for the treatment of diseases in humans.  The company is most well known for its drug Recothrom, which is used to reduce bleeding during surgery. -Michael B. Sauter (Source: BioHealth Investor) BioHealth Investor news http://www.medworm.com/rss/comments.php?id=3944657 Wed, 08 Sep 2010 14:09:53 +0100 3944657 http://www.medworm.com/index.php?rid=3940841&cid=s_35775_34_f&fid=35775&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FBiohealthInvestor%2F%7E3%2FiZGBmhcYjLQ%2Fk-v-hangs-on-to-nyse-listing.html K-V Pharmaceutical Company (NYSE: KV-A) was down $0.25 (13.89%) to $1.55 today, leaving the company closer to the low end of their 52-week range of $0.61 to $5.36.  This past Thursday the company announced that stocks had traded above the average NYSE required price of $1.00 throughout August, thereby preserving their NYSE listing. K-V Pharmaceutical Co. is a biopharma company based out of Bridgeton, Missouri.  The company creates and sells branded and generic prescription pharmaceutical products, as well as distributing their products through a number of various carriers. -Michael B. Sauter (Source: BioHealth Investor) BioHealth Investor news http://www.medworm.com/rss/comments.php?id=3940841 Tue, 07 Sep 2010 15:27:22 +0100 3940841 http://www.medworm.com/index.php?rid=3940842&cid=s_35775_34_f&fid=35775&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FBiohealthInvestor%2F%7E3%2F9Q5DdjGPAuE%2Findenix-suffers-from-fda-hold.html Shares of biopharma company Indenix Pharmaceuticals, Inc. (NASDAQ: IDIX) dropped dramatically following news that the company’s two leading hepatitis C programs, IDX184 and IDX320, had been put on clinical hold by the Food and Drug Administration.  The move was made after three patients in the drug trial demonstrated signs of liver toxicity, implying that the drugs pose possible threats to users’ health. The company, as a result, has gone from one of one of the industry’s top-performing companies to one of the quickest percentage price losers.  And, despite Indenix chairman and CEO Jean-Pierre Sommadossi’s claim that the company would “remain committed to the future potential of these drug[s],” shares plummeted 55% in premarket trading this morning. -M... BioHealth Investor news http://www.medworm.com/rss/comments.php?id=3940842 Tue, 07 Sep 2010 15:01:37 +0100 3940842 http://www.medworm.com/index.php?rid=3923151&cid=s_35775_34_f&fid=35775&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FBiohealthInvestor%2F%7E3%2FKaI46khzJsg%2Feli-lilly-earns-major-win-as-appeals-court-upholds-evista-ban-lly-teva.html According to Reuters, Eli Lilly & Co. (NYSE: LLY) won a major battle against Teva Pharmaceutical Industries Limited (NASDAQ: TEVA), which had been petitioning for a generic version of Lilly’s drug, Evista. The court upheld the patent on Evista, which is used to treat Osteoporosis. -Michael B. Sauter (Source: BioHealth Investor) BioHealth Investor news http://www.medworm.com/rss/comments.php?id=3923151 Wed, 01 Sep 2010 16:43:35 +0100 3923151 http://www.medworm.com/index.php?rid=3923152&cid=s_35775_34_f&fid=35775&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FBiohealthInvestor%2F%7E3%2FSSTCCAbzZkI%2F3289.html Inhibitex Inc. (NASDAQ: INHX) was up $0.16 (11.27%) this morning to $1.58 on news that the company had completed a Phase1a, single ascending dose trial of its nucleotide polymerase inhibitor, INX-189.  The drug is currently being developed for the treatment of chronic hepatitis C.  Tests of the drug have, at this point, been positive with no serious side effects. Inhibitex Inc. is a biopharma company that specializes in the development of drugs used to prevent infective diseases, primarily shingles and hepatitis C. -Michael B. Sauter (Source: BioHealth Investor) BioHealth Investor news http://www.medworm.com/rss/comments.php?id=3923152 Wed, 01 Sep 2010 16:16:26 +0100 3923152 http://www.medworm.com/index.php?rid=3923153&cid=s_35775_34_f&fid=35775&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FBiohealthInvestor%2F%7E3%2FWJyG120srE0%2Fintendis-enters-deal-with-kythera-for-fat-reduction-drug.html Intendis, Bayer Healthcare’s dermatology sector, has signed a deal with Los Angeles-based biopharma company Kythera Biopharmaceuticals in which the company receives rights to Kythera’s lead product candidate, ATX-101, in areas outside of the United States and Canada.  Kythera, in return, will receive $43 million upfront and up to $330 million beyond their initial payment.  ATX-101 is used to destroy fat cells in localized areas beneath the chin while leaving healthy tissue.  In addition to this, as is covered under the deal with Intendis, Kythera is looking to find other areas in which the drug can be used to destroy fat cells. Intendis CEO Marc Lafeuille commented on the deal, “”As a first-in-class candidate being studied for minimally-invasive fat reduction, ... BioHealth Investor news http://www.medworm.com/rss/comments.php?id=3923153 Wed, 01 Sep 2010 15:53:18 +0100 3923153 http://www.medworm.com/index.php?rid=3918295&cid=s_35775_34_f&fid=35775&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FBiohealthInvestor%2F%7E3%2F3qzqH5jc5DQ%2Fpluristem-placental-cells-found-effective-for-several-treatments.html Pluristem Therapeutics, Inc. (NASDAQ: PSTI) is up 12.87% this morning after it announced that its PLX therapeutic stem cell line, derived from the material of a human placenta, would be the only type of cell selected for a study designed to prevent inflammatory heart disease, also called diastolic heart failure. Shares of PSTI is up $0.13 to $1.14 on 172 thousand shares of volume, more than three times the average daily volume of 48,248 shares. the stock is mid-way through its 52-week range of $0.82 to $1.52. -Michael B. Sauter (Source: BioHealth Investor) BioHealth Investor news http://www.medworm.com/rss/comments.php?id=3918295 Mon, 30 Aug 2010 15:37:22 +0100 3918295 http://www.medworm.com/index.php?rid=3918296&cid=s_35775_34_f&fid=35775&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FBiohealthInvestor%2F%7E3%2FT-0-jBu59os%2Faveo-discovers-potential-cancer-breakthrough.html AVEO Pharmaceuticals Inc. (NASDAQ: AVEO) was up $0.75 (9.14%) this morning to $8.96 following reports that by introducing an experimental drug during chemotherapy the company had succeeded to wipe out brain cancer cells in mice.  This news provides hope for a new treatment for the disease in humans, and testing in humans has already begun. AVEO Pharmaceuticals Inc. is a biopharma company that specializes in cancer therapeutics.  Up until 2005 the company was known as GenPath Pharmaceuticals. -Michael B. Sauter (Source: BioHealth Investor) BioHealth Investor news http://www.medworm.com/rss/comments.php?id=3918296 Mon, 30 Aug 2010 15:03:39 +0100 3918296 http://www.medworm.com/index.php?rid=3918297&cid=s_35775_34_f&fid=35775&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FBiohealthInvestor%2F%7E3%2Fyf8e0URN7wE%2Fsanofi-aventis-forcibly-rejected-in-genzyme-bid.html For the past several months, rumors and reports have flown about French pharmaceutical behemoth Sanofi-Aventis (NYSE: SNY) devoting heavy resources to acquiring American research company Genzyme Corporation (NASDAQ: GENZ). The firms have gone back and forth on offers since early last month. Today, the Genzyme rejected Sanofi’s latest effort. Genzyme CEO explained his company’s actions, decrying an “unrealistic starting package” and said their offer “dramatically undervalues our company.” Shares of GENZ are up 3.77 today on much higher than average volume. SNY is up .24% on average volume. -Michael B. Sauter (Source: BioHealth Investor) BioHealth Investor news http://www.medworm.com/rss/comments.php?id=3918297 Mon, 30 Aug 2010 14:55:57 +0100 3918297 http://www.medworm.com/index.php?rid=3918298&cid=s_35775_34_f&fid=35775&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FBiohealthInvestor%2F%7E3%2FCnMGqm6Xgm4%2Froche-cancer-drug-does-not-receive-fda-approval.html Swiss drugmaker Roche took a blow this past Friday after the U.S. FDA denied the company’s request for accelerated approval regarding trastuzumab-DM1, or T-DM1.  The drug, according to Reuters, “comprises ImmunoGen’s DM1 cancer-cell-killing agent linked to the HER2-targeting antibody trastuzumab, or Herceptin,” as a means of combating cancer.  The FDA’s decision will now setback the drug, which Roche hoped to gain approval for this year, to a 2012 resubmission date. T-DM1 was found to reduce the size of tumors in one third of the women with advanced breast cancer tested during drug trials.  In reaction to news of the the FDA’s refuse-to-file letter, Vontobel analyst Andrew Weiss stated, “The impact to (Roche) earnings is marginal.  However, the... BioHealth Investor news http://www.medworm.com/rss/comments.php?id=3918298 Mon, 30 Aug 2010 14:48:39 +0100 3918298 http://www.medworm.com/index.php?rid=3905752&cid=s_35775_34_f&fid=35775&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FBiohealthInvestor%2F%7E3%2F4A_Ujy_gf80%2Fgsk-gets-boost-as-shingles-vaccine-enters-late-stage-agen-goes-along-for-ride-gsk-agen.html GlaxoSmithKline’s (NYSE: GSK) new shingles recently entered phase III trials, and is expected to breeze through these as well. Meanwhile, Antigenics Inc. (NYSE: AGEN) the company responsible for the vaccine’s adjuvant, also experienced a major jump yesterday. Shares of GSK are up .56% today to $37.63. Shares of AGEN are down 3.68% to $0.82, but this should be seen as more of a minor correction after gaining nearly 12% yesterday. AGEN has traded 508 thousand shares today so far, with an average volume of 557 thousand. -Michael B. Sauter (Source: BioHealth Investor) BioHealth Investor news http://www.medworm.com/rss/comments.php?id=3905752 Thu, 26 Aug 2010 17:42:00 +0100 3905752 http://www.medworm.com/index.php?rid=3905753&cid=s_35775_34_f&fid=35775&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FBiohealthInvestor%2F%7E3%2F3XIsfHQ3GcE%2Fdara-biopharma-faces-delisting-dara.html DARA Biosciences, inc. (NASDAQ: DARA) is on the chopping block after being notified by the SEC that the company didn’t meet the minimum equity requirement to continue to be publicly traded on the NASDAQ. The market’s minimum requirement is $2.5 million, and, according to the pharma company’s 10-Q report, it no longer meets that standard. If it cannnot prove that it has returned to this equity level by august 27th, DARA will officially be delisted from the market. According to Yahoo! Finance, the company plans a repeal, and hopes to work out an alternative to its removal from public trading. -Michael B. Sauter (Source: BioHealth Investor) BioHealth Investor news http://www.medworm.com/rss/comments.php?id=3905753 Thu, 26 Aug 2010 15:36:55 +0100 3905753 http://www.medworm.com/index.php?rid=3905754&cid=s_35775_34_f&fid=35775&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FBiohealthInvestor%2F%7E3%2FYhKl5plgni8%2Fgenzyme-faces-merger-bid-from-sanofi.html Sanofi-Aventis SA (NYSE: SNY) has raised it’s final offer for the purchase of Genzyme (NASDAQ: GENZ) to $70 a share, up one dollar from their initial offer of $69.  The price is certainly not one to thrill those at Genzyme, however insiders report that Sanofi holds concerns over manufacturing setbacks at the company. “Sanofi doesn’t want to overpay and is being very reasonable,” reported Jerome Feronis from Banque Martin Maurel in Marseille, who helps manage Sanofi shares. “There are real issues tied to Genzyme. They want to pay a fair price. It’s good management.” As activist directors seek to drive up the price, however, Sanofi may end up having to pay as much as $80 a share.   Alternately, Genzyme does not currently have any other offers from American companies, and... BioHealth Investor news http://www.medworm.com/rss/comments.php?id=3905754 Thu, 26 Aug 2010 14:04:56 +0100 3905754 http://www.medworm.com/index.php?rid=3901508&cid=s_35775_34_f&fid=35775&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FBiohealthInvestor%2F%7E3%2FuZzrO4xd12c%2Fthe-worm-turns-in-genzyme-sanofi-deal-genz-sny.html We have cautioned about the value of Genzyme Corporation (NASDAQ: GENZ) if Sanofi-Aventis (NYSE: SNY) either doesn’t raise a bid or if it walks away.  The wild card is that Genzyme is taking its sweet time and it could be pushing Sanofi away. We have heard and read that the implied original offer around $69 has not gotten the greatest reception from Genzyme’s board.  How quickly they forget that their shares aren’t there because of their own woes. Now it appears that Sanofi-Aventis might not budge.  Report from Bloomberg, Reuters, and CNBC indicate that a peak of the offer is around $70 per share.  This probably won’t drive the board of Genzyme to pounce all over the offer. Bloomberg also reported that Sanofi-Aventis may decide to look elsewhere for other acquis... BioHealth Investor news http://www.medworm.com/rss/comments.php?id=3901508 Wed, 25 Aug 2010 16:59:41 +0100 3901508 http://www.medworm.com/index.php?rid=3901509&cid=s_35775_34_f&fid=35775&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FBiohealthInvestor%2F%7E3%2Fi0iMedVJKaU%2Fsomaxon-teams-with-procter-gamble-regarding-new-drug.html Somaxon Pharmaceuticals Inc. (NASDAQ: SOMX) jumped $1.39 (41.25%) to $4.76 today on news that the biopharma company had signed a deal with Procter & Gamble to market the company’s new insomnia drug, Silenor.  In return for helping Somaxon sell the drug, which is a low-dose from of doxepin, P & G will gain first rights to develop and market the drug as an over-the-counter medication.  The pact will run through the end of 2012, but it is renewable. Somaxon deals primarily with the treatment of diseases and disorders in the central nervous system.  Silenor will be the company’s principal product. -Michael B. Sauter (Source: BioHealth Investor) BioHealth Investor news http://www.medworm.com/rss/comments.php?id=3901509 Wed, 25 Aug 2010 14:40:58 +0100 3901509 http://www.medworm.com/index.php?rid=3897902&cid=s_35775_34_f&fid=35775&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FBiohealthInvestor%2F%7E3%2FTGjAI-1u8vY%2Fstem-cell-breakthrough-offers-possible-treatments-for-baldness-and-more.html In a recent breakthrough for stem cell technology, Swiss and Scottish scientists at the University of Lausanne in Switzerland discovered that when stem cells from the thymus were transplanted into the developing skin of rats, new follice cells, capable of hair-growth, were created.  These cells are more potent than normal hair follicle stem cells, supporting hair for a year rather than a week, implying a possible cure for human baldness. This breakthrough, which was not the original aim of the scientists, also raises possibilities for different outcomes when the thymus cells are combined with cells other than skin.  A new cell, they have discovered, that can be transformed by its environment. (Source: BioHealth Investor) BioHealth Investor news http://www.medworm.com/rss/comments.php?id=3897902 Tue, 24 Aug 2010 20:00:47 +0100 3897902 http://www.medworm.com/index.php?rid=3897903&cid=s_35775_34_f&fid=35775&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FBiohealthInvestor%2F%7E3%2FxDTQgNwr1f8%2Fprana-biotechnology-secures-crucial-patents-in-europe-and-the-u-s.html Prana Biotechnology (NASDAQ: PRAN) is up 8.77% a half hour before close after announcing this morning that it had secured several key patent extensions from the United States Patents and Trademark Office (USPTO) and the European Patent Office (EPO). The company recieved received up to 2.5-year extensions for its PBT2 line, which has been used to treat Alzheimer’s disease. The extension was granted in part because it is now considered a valid treatment for Huntington’s disease as well. The company has traded 44,529 shares in volume, above it’s average volume of approximately 40 thousand. PRAN, which is currently priced at $1.18 is close to its 52-week low of $1.02. -Michael B. Sauter (Source: BioHealth Investor) BioHealth Investor news http://www.medworm.com/rss/comments.php?id=3897903 Tue, 24 Aug 2010 19:50:57 +0100 3897903 http://www.medworm.com/index.php?rid=3897904&cid=s_35775_34_f&fid=35775&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FBiohealthInvestor%2F%7E3%2FNHyMf_gdHs8%2Fstreamlines-audit-solution-picked-up-by-childrens-national.html Streamline Health Solutions Inc. (NASDAQ: STRM) was up $0.12 (11.76%) today to $1.14 on news that the company’s Audit Compliance for the Enterprise Solution had been implemented at Children’s National in Washington, DC.  The audit solution was introduced by Streamline earlier this year, and officials at Children’s Nation report that they have already benefited from the system. Streamline Health Solutions Inc. is an information management company for the healthcare industry. (Source: BioHealth Investor) BioHealth Investor news http://www.medworm.com/rss/comments.php?id=3897904 Tue, 24 Aug 2010 19:19:09 +0100 3897904 http://www.medworm.com/index.php?rid=3897905&cid=s_35775_34_f&fid=35775&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FBiohealthInvestor%2F%7E3%2FryD10G9byhM%2Ffda-shoots-down-jazz-pharmaceuticals-fibromyalgia-treatment.html Jazz Pharmaceuticals (NASDAQ: JAZZ) lost one of its development-stage drugs today when an FDA panel vetoed JZP-6, which was designed to treat Fibromyalgia, a painful nervous disorder. According to Reuters, one of the main reasons for the denial was the presence of hydroxybutyrate (GHB) which is known colloquially as “the date rape drug.” The panel voted overwhelmingly against the drug (20-2) with panelists explaining their main reasons were concerns for abuse, as well as a lack of proof that the drug will perform any better than current treatments. The panel was not entirely pessimistic, and suggested Jazz go back to the drawing board on the treatment. -Michael B. sauter (Source: BioHealth Investor) BioHealth Investor news http://www.medworm.com/rss/comments.php?id=3897905 Tue, 24 Aug 2010 16:12:05 +0100 3897905 http://www.medworm.com/index.php?rid=3893946&cid=s_35775_34_f&fid=35775&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FBiohealthInvestor%2F%7E3%2FdgkqAzHZBh8%2Fthe-case-grows-against-all-that-jazz-jazz.html Jazz Pharmaceuticals Inc. (NASDAQ: JAZZ) is having an awful day, and frankly this is a situation that could have been even worse for holders considering the speculative phase that the company is in versus its existing portfolio. The FDA advisory committee voted against Jazz’s fibromyalgia candidate in a voted tallied at 20-2 against approval.  The committee noted that risks outweigh the benefits.  The FDA also asked it to review the risk evaluation mitigation strategy. We wanted to see what else Jazz has.  Its Xyrem is on the market to treat excessive daytime sleepiness and cataplexy and Luvox CR to treat OCDs and social anxiety disorder. Xyrem is currently the major source of the firm’s revenues (about 80% on last count).  The company’s pipeline has targets aimed at bipo... BioHealth Investor news http://www.medworm.com/rss/comments.php?id=3893946 Mon, 23 Aug 2010 19:40:18 +0100 3893946 http://www.medworm.com/index.php?rid=3893947&cid=s_35775_34_f&fid=35775&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FBiohealthInvestor%2F%7E3%2F00njE-PdYAc%2Fbiodel-gains-despite-losses.html Biodel Inc. (NASDAQ: BIOD) was up $0.32 (7.73%) today to $4.46 despite recent reports of a Q3 net loss of $8.6 million, or $0.36 per share.  The company possessed shares valued at almost $20 in the summer of 2008, however investor interest has since waned considerably.  Possible FDA approval of the company’s device that device that injects insulin into the bloodstream more rapidly than other methods could possibly could come this year, perhaps, effectively restoring the company’s popularity. Biodel Inc. is a biopharma company that specializes in treatments for diabetes. -Michael B. Sauter (Source: BioHealth Investor) BioHealth Investor news http://www.medworm.com/rss/comments.php?id=3893947 Mon, 23 Aug 2010 18:33:15 +0100 3893947 http://www.medworm.com/index.php?rid=3893948&cid=s_35775_34_f&fid=35775&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FBiohealthInvestor%2F%7E3%2FlYoLr9C3dzE%2Fepicept-concerns-growing-much-stronger-epct.html EpiCept Inc. (NASDAQ: EPCT) may be facing an even less promising future as you might have guessed based on a $1.10 closing price with a $55 million market-cap on Friday.  Shares are getting butchered on Monday as a result of an FDA denial in acceptance of its new drug application for Ceplene which the company submitted to the FDA at the end of June. The drug candidate had an indication as combination treatment along with interleukin-2 as a cancer fighting agent to prevent or to help prevent the recurrence of acute myeloid leukemia (AML).  The FDA denial of the market application approval was due to questions about efficacy.  Never a good sign, particularly since Ceplene is approved in Europe and was under an orphan drug designation here in the U.S. Ceplene is being marketed by its partn... BioHealth Investor news http://www.medworm.com/rss/comments.php?id=3893948 Mon, 23 Aug 2010 16:17:06 +0100 3893948 http://www.medworm.com/index.php?rid=3883679&cid=s_35775_34_f&fid=35775&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FBiohealthInvestor%2F%7E3%2FGRalL3XDin8%2Fcoalition-purchases-inc-research.html A coalition of Avista Capital Partners and the Ontario Teachers’ Pension Plan have apparently agreed on a price for INC research, a drug development firm which specializes in pediatrics and women’s health issues. The companies are expected to pay $600 million for the deal, which has not been formally announced as of yet. -Michael B. Sauter (Source: BioHealth Investor) BioHealth Investor news http://www.medworm.com/rss/comments.php?id=3883679 Thu, 19 Aug 2010 20:03:57 +0100 3883679 http://www.medworm.com/index.php?rid=3883680&cid=s_35775_34_f&fid=35775&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FBiohealthInvestor%2F%7E3%2FFloO_kHyYBw%2Fk-v-makes-significant-gains.html K-V Pharmaceutical Company (NYSE: KV-A) was up $0.12 (8.28%) today to $1.57 on no news. K-V Pharmaceutical Co. is a biopharma company based out of Bridgeton, Missouri.  The company creates and sells branded and generic prescription pharmaceutical products, as well as distributing their products through a number of various carriers. (Source: BioHealth Investor) BioHealth Investor news http://www.medworm.com/rss/comments.php?id=3883680 Thu, 19 Aug 2010 18:18:03 +0100 3883680 http://www.medworm.com/index.php?rid=3883681&cid=s_35775_34_f&fid=35775&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FBiohealthInvestor%2F%7E3%2F8xla3LpfBxM%2Fstem-cells-show-more-paralysis-reversal-hope-stem.html StemCells, Inc. (NASDAQ: STEM) is the talk of the town this morning after it showed published reports of a mice study using human neural stem cells reverse paralysis. The publication of new preclinical data showed that the company’s proprietary human neural stem cells restored lost motor function in mice with chronic spinal cord injury. This is the first published study to show that human neural stem cells can restore mobility even when administered at time points beyond the acute phase of trauma. The company suggests that the prospect of treating a much broader population of injured patients is now more than previously demonstrated. The paper was published yesterday in the international peer-reviewed journal PLoS ONE, and is available online at http://dx.plos.org/10.1371/journal.pon... BioHealth Investor news http://www.medworm.com/rss/comments.php?id=3883681 Thu, 19 Aug 2010 12:06:41 +0100 3883681 http://www.medworm.com/index.php?rid=3879009&cid=s_35775_34_f&fid=35775&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FBiohealthInvestor%2F%7E3%2FC55DBz0yhUw%2Fcardica-signs-new-deal-with-intuitive.html Cardica Inc. (NASDAQ: CRDC), was up $0.45 (27.11%) this afternoon to $2.11 per share.  This move is the result of a new, $12 million deal signed between Cardica and Intuitive Surgical Inc. (NASDAQ: ISRG).  As a result of the deal, Intuitive has exclusive rights to Cardica’s intellectual property pertaining to robotic surgery. Cardica Inc. is a medical instruments company that makes surgical devices for cardiac, among other, procedures. -Michael B. Sauter (Source: BioHealth Investor) BioHealth Investor news http://www.medworm.com/rss/comments.php?id=3879009 Wed, 18 Aug 2010 18:15:13 +0100 3879009 http://www.medworm.com/index.php?rid=3879010&cid=s_35775_34_f&fid=35775&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FBiohealthInvestor%2F%7E3%2FDqGu0nsR_NA%2Freturn-of-ten-bagger-hunts-bsd-medical-bsdm.html When you see a 100% gain in a medical device or medical systems company, generally it is a takeover.  This morning that is not the case at BSD Medical Corporation (NASDAQ: BSDM).  But the initial pricing action is showing that BSD Medical Systems is the next low-priced stock that may be trying to exhibit some of the old ten-bagger ambitions for its shares. The company just announced FDA Marketing clearance to market its MicroThermX Microwave Ablation System (MTX-180) for ablation of soft tissue, giving it the right to sell MTX-180 in the United States. The MTX-180 was designed to provide a higher power, optimized system targeted to the growing therapeutic interventional and surgical oncology market. The MTX-180 was developed and patented by BSD to deliver targeted microwave energy to des... BioHealth Investor news http://www.medworm.com/rss/comments.php?id=3879010 Wed, 18 Aug 2010 14:00:53 +0100 3879010 http://www.medworm.com/index.php?rid=3870891&cid=s_35775_34_f&fid=35775&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FBiohealthInvestor%2F%7E3%2Fs8cNzEOjeAg%2Fpacbio-files-for-ipo.html Pacific Biosciences, the California-based Gene Sequencing company, has made the decision to become public.  The company filed for a $200 million IPO, hoping to raise money for R&D of its products and product technology, as well as general corporate purposes..  This move will effectively make PacBio one of the most successful DNA-sequencing companies traded in the public markets. PacBio has previously raised $370 million in venture capital.  This is important however, as competition has become prominent as DNA sequencing technology has become faster and cheaper for companies across the board. -Michael B. Sauter (Source: BioHealth Investor) BioHealth Investor news http://www.medworm.com/rss/comments.php?id=3870891 Mon, 16 Aug 2010 19:37:23 +0100 3870891 http://www.medworm.com/index.php?rid=3870892&cid=s_35775_34_f&fid=35775&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FBiohealthInvestor%2F%7E3%2FwEUqJw7aLP0%2Fcarl-icahn-paring-down-in-biotech-sort-of-anx-biib-enzn-genz.html Adventrx Pharmaceuticals, Inc. (AMEX: ANX) no longer has to answer to Carl Icahn.  The 13-F filings from Icahn Enterprise hit today and the roughly 4.3 million shares held as of March 31 is not listed in the June 30, 2010 portfolio holdings. Icahn’s holdings of 3.2+ million shares of Biogen idec Inc. (NASDAQ: BIIB), 704,214 shares of Enzon Pharmaceuticals Inc. (NASDAQ: ENZN) and 2.62 million shares of Genzyme Corp. (NASDAQ: GENZ) appear to be the same as before. Adventrx Pharmaceuticals’ stock is trading up 1.6% at $1.87 versus a 52-week trading range of $1.50 to $13.00.  This trading range is of course on a post-split adjustment basis after its 1-for-25 reverse stock split went into effect in April.  It seems that Mr. Icahn is no fan of reverse splits either. JON C. OGG (So... BioHealth Investor news http://www.medworm.com/rss/comments.php?id=3870892 Mon, 16 Aug 2010 17:00:23 +0100 3870892 http://www.medworm.com/index.php?rid=3870893&cid=s_35775_34_f&fid=35775&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FBiohealthInvestor%2F%7E3%2F_F3TaDoGFs4%2Fdb-sizes-up-biotech-in-new-research-calls-amgn-biib-celg-dndn-genz-gild.html Deutsche Bank is looking positive on a couple of the larger biotech names this morning after the firm initiated analyst research coverage.  Unfortunately, the bulk of the big biotech shops have HOLD ratings and very unenthusiastic price targets.  Whatever the new normal is, it is not looking stellar for the largest biotech names out there. Amgen Inc. (NASDAQ: AMGN) Started as HOLD with a $57 price target. Biogen Idec Inc. (NASDAQ: BIIB) Started as HOLD with a $57 price target. Celgene Corporation (NASDAQ: CELG) Started as HOLD with a $56 price target. Dendreon Corporation (NASDAQ: DNDN) Started as BUY with a $44 price target. Genzyme Corporation (NASDAQ: GENZ) Started as HOLD with a $72 price target. Gilead Sciences Inc. (NASDAQ: GILD) Started as BUY with a $42 price target. JON C. OGG (... BioHealth Investor news http://www.medworm.com/rss/comments.php?id=3870893 Mon, 16 Aug 2010 16:13:38 +0100 3870893 http://www.medworm.com/index.php?rid=3863859&cid=s_35775_34_f&fid=35775&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FBiohealthInvestor%2F%7E3%2FedKNw3PX_io%2Fhow-safe-is-teva-teva.html This week we started compiling a list of safe stocks for a new bear market, and Teva Pharmaceutical Industries Limited (NASDAQ: TEVA) came up in our screens.  We ran the piece during this morning there, and unfortunately the slide continued on Friday. For starters, these are of course very long term in nature.  Pharmaceutical stocks have historically offered safe havens during harder times due to the nature of your life depending upon them.  Healthcare reform is changing that and many drug stocks have been dead money for quite some time. Teva does have a disadvantage over some of the other large-cap pharma stocks.  Its dividend is low.  It is also based in Israel, but most of its revenue comes from North America. The latest quarter’s North America revenues rose 17% to $2.48 bill... BioHealth Investor news http://www.medworm.com/rss/comments.php?id=3863859 Fri, 13 Aug 2010 20:26:50 +0100 3863859 http://www.medworm.com/index.php?rid=3860445&cid=s_35775_34_f&fid=35775&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FBiohealthInvestor%2F%7E3%2FQdSZT0dhSDo%2F3188.html In an effort to combat Alzheimer’s disease, global health care giant Merck & Company, Inc. (NYSE: MRK) has entered into a deal for $289 million with Canada’s Alectos Therapeutics to develop new therapeutic molecules.  The deal is meant to jumpstart a collaboration between the two companies to tackle the enzyme O-linked N-acetylglucosaminidase, which is believed to have causal effects in the development of Alzheimer’s disease. Merck has experienced poor results in the past with regards to treating Alzheimer’s, however outlook seems positive with this new outing. -Michael B. Sauter (Source: BioHealth Investor) BioHealth Investor news http://www.medworm.com/rss/comments.php?id=3860445 Thu, 12 Aug 2010 16:02:25 +0100 3860445 http://www.medworm.com/index.php?rid=3856763&cid=s_35775_34_f&fid=35775&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FBiohealthInvestor%2F%7E3%2FadZyEM5CseI%2Fjazz-up-despite-q2-loss.html Jazz Pharmaceuticals, Inc. (NASDAQ: JAZZ) was up $0.88 (9.31%) today to $10.33 following a Q2 loss of $6.4 million due to a debt extinguishment.  The company also raised its expected 2010 EPS to between 32 cents and 41 cents per share from the previous expected earnings of between 26 and 41 cents. Jazz Pharmaceuticals, Inc. is a biopharma company that develops and sells products for neurology and psychiatry.  The company’s products include Xyrem, used to treat excessive daytime sleepiness, and Luvox CR, used to treat obsessive compulsive disorder and social anxiety disorder. -Michael B. Sauter (Source: BioHealth Investor) BioHealth Investor news http://www.medworm.com/rss/comments.php?id=3856763 Wed, 11 Aug 2010 18:47:57 +0100 3856763 http://www.medworm.com/index.php?rid=3852202&cid=s_35775_34_f&fid=35775&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FBiohealthInvestor%2F%7E3%2FX4uVHyhZMwg%2Fpfizer-wins-fda-approval-for-new-syringe.html Pfizer, Inc. (NYSE: PFE) was up $0.13 (0.79%) today following the FDA’s approval of a Prefilled Dual-Chamber Syringe for administration of the company’s XYNTHA® Antihemophilic Factor (Recombinant) Plasma/Albumin-Free to patients for the treatment of hemophilia A.  Pfizer stock is presently trading at $16.55. Pfizer, Inc. is a biopharm company develops and manufactures a variety of prescription medications.  The company’s products include Lipitor, Norvasc, Caduet, and Lyrica. -Michael B. Sauter (Source: BioHealth Investor) BioHealth Investor news http://www.medworm.com/rss/comments.php?id=3852202 Tue, 10 Aug 2010 19:01:57 +0100 3852202 http://www.medworm.com/index.php?rid=3852203&cid=s_35775_34_f&fid=35775&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FBiohealthInvestor%2F%7E3%2FIxHXuHuoe4E%2Fsciclone-under-investigation-for-corrupt-overseas-practices.html SciClone Pharmaceuticals, Inc. (NASDAQ: SCLN) was down 32.48% today, a share value loss of $1.14.  This major drop is the result of a recent report in a 10-Q filing yesterday which stated that the company’s activity in foreing markets is being investigated by both the SEC and the Department of Justice.  As a result, the company admits that the legal matters will “require [them] to expend significant management time and incur significant legal and other expenses.” SciClone Pharmaceuticals, Inc. is a biopharm company that specializes in therapeutics for the treatment of cancer and other diseases in the People’s Republic of China, among other countries. -Michael B. Sauter (Source: BioHealth Investor) BioHealth Investor news http://www.medworm.com/rss/comments.php?id=3852203 Tue, 10 Aug 2010 18:22:08 +0100 3852203 http://www.medworm.com/index.php?rid=3847238&cid=s_35775_34_f&fid=35775&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FBiohealthInvestor%2F%7E3%2FONryRsdgQvw%2Fpenwest-plans-big-changes.html Penwest Pharmaceuticals Co. (NASDAQ: PPCO) was up $0.58 (13.78%) today to $4.79 after announcing a number of changes to the company’s corporate governance practices, as well as appointing Kevin C. Tang as chairman of the board.  In an address to shareholders Tang wrote, “The Board will take prompt and thoughtful action to wind down substantially all of the Company’s operations in order to preserve the full value of the Opana ER royalty stream for the benefit of shareholders,” implying a desire to move the company somewhere towards liquidation. Penwest Pharmaceuticals Co. is a biopharm company that develops drugs, primarily for disorders of the nervous system.  The company’s forthcoming changes reflect a move to make the Board more responsive to shareholder input. -Micha... BioHealth Investor news http://www.medworm.com/rss/comments.php?id=3847238 Mon, 09 Aug 2010 18:14:16 +0100 3847238 http://www.medworm.com/index.php?rid=3847239&cid=s_35775_34_f&fid=35775&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FBiohealthInvestor%2F%7E3%2Fhsfnn8r6E8E%2Fgenentech-and-roche-review-curis-mid-stage-cancer-therapy-failure-cris-dna.html In a move that has potentially enormous repercussions for bio-pharmaceutical company Curis Inc., (NASDAQ: CRIS) big-name collaborators Genentech Inc. (NYSE: DNA) and Roche will begin a thorough evaluation of the developer’s GDC-0449 drug. This analysis is intended to determine whether the treatment, which failed mid-stage clinical trials for colon cancer, is successful as a treatment for ovarian cancer. If the treatment is found to be again unsuccessful, it would signal a huge blow to Curis. Shares of CRIS dropped more than 10% on news of a Genentech/Roche announcement. -Michael B. Sauter (Source: BioHealth Investor) BioHealth Investor news http://www.medworm.com/rss/comments.php?id=3847239 Mon, 09 Aug 2010 17:22:42 +0100 3847239