Aastrom Announces Phase II Clinical Results, Shares Sink

Good and Bad news for Aastrom Biosciences today.  Shares dropped heavily after Reuters reports that Aastrom's potential stem cell therapy did not meet a secondary endpoint for it's Phase II clinical trial for the treatment of Critical Limb Ischemia which can cause amputation in those who suffer from the disease.  I have seen this a few times lately, where a stock receives generally positive news, only to come crumbling down.  Aastrom simply rose too fast, too soon.

Yahoo Finance:  Aastrom Biosciences--(ASTM)

Aastrom Ischemia Therapy Data Disappoint; Shares Tank

*  Says study meets main safety and efficacy goal

*  Did not show significant amputation free survival
*  Shares fall 36 pct

Nov 18 (Reuters) - Aastrom Biosciences Inc (ASTM.O) reported its experimental ischemia treatment met its main goals, but the company's shares, which had soared in anticipation of the data, crashed as the secondary goal of the trial was not met.

The study met the primary goals of safety and efficacy in patients with critical limb ischemia (CLI), a cardiovascular condition that often leads to amputation of the limbs.

CLI is a painful condition caused by obstructions in the arteries that decreases blood flow to the limbs with no medical therapy available at present.

Human Genome Sciences Shares Decline After FDA Recommend Benlysta

Elmo the Investment Banker is killing traders. 
Stick to Sesame Street Elmo. 
You aren't cut out for Wall St.

Just after Tuesday's FDA Recommendation for Human Genome Sciences' Lupus Therapy Benlysta, Citigroup and Bank of America downgraded the stock.  Obviously, they mistakenly shorted the stocks and wanted to get their money back after guessing wrong on the FDA decision.  The drug was recommended by a 13-2 vote.  It is very similar to other cases in recent FDA Approvals, where the stock has actually has gone down on good news, not up.

Manipulating shorts cover their positions by making sure they got analysts on their side to downgrade a stock in case a Panel vote goes against them. Here is a perfect example of how Hedge Fund Shorts cover their positions:

Two downgrades Wednesday morning, one each from Citi and Bank of America/Merrill Lynch, reflected these new concerns and sent Human Genome shares down 7% to $23.98 in early trading.

An advisory panel convened by the U.S. Food and Drug Administration voted 13-2 Tuesday night to recommend Benlysta's approval as the first new lupus therapy in 50 years.

Human Genome Sciences Gains FDA Recommendation for Benlysta. Shares Soar 10% in Afterhours Trading

Good news today for Human Genome Sciences and those who suffer from Lupus.  FDA voted in favor of Benlysta with a strong vote of 13-2.  Although the FDA doesn't always approve drugs that are recommended by the panel, many times they do, and more so with an Approval Recommendation than without one.  Shares of Human Genome Sciences were up 10.51% to 28.60 in afterhours trading. 

Trading was halted throughout the day and will resume normal trading tomorrow.  I expect a strong day tomorrow and it should be watched closely tomorrow.  It's partner Glaxo SmithKline was trading slightly higher at 39.45 +0.91 a 2.36% gain.  This is really good news for investors who have watched HGSI drop from a high of  30.18 in September to a low of 23.60 this past Friday from a Doctor scandal, a CRL for Zalbin, and safety concerns from their Phase III clinical trial results for Benlysta. 

It did report positive 3Q 2010 results in the following press release,  Human Genome Sciences Announces Third Quarter 2010 Financial Results and Key Developments.  I see HGSI stock to rise towards the 32-35 mark with possible Full Approval coming December 9th.  

Please follow BioPharma Investor for more Biotech and Pharmaceuticals News and FDA recommendations.  I do my best to provide up to date news and extensive stock research in the BioPharma field.  Subscribe in a Reader powered by Feedburner or join to have updates sent to your email.  It's all free.

Yahoo Finance--HGSI
Google Finance--HGSI

Yahoo Finance--GSK
Google Finance--GSK

FDA panel favors lupus drug from Human Genome Sciences despite mixed results in studies

Tuesday's FDA Panel Review for Human Genome Science's Benlysta

Purple Walk for Lupus Awareness

Everything you need to know about Tuesday's FDA panel recommendation for Human Genome Sciences therapy for Lupus, Benlysta.  If approved Benlysta would be the first approved therapy in 50 years for Lupus.  Friday the FDA released the notes for the upcoming panel review Tuesday, November 16th.  Concerns for the panel Tuesday were an increased risk of suicide, risk of infection, and decreased efficacy in African-American patients, who are more prone to Lupus.  Forbes' The Medicine Show Blog with Matthew Herper highlighted some of these concerns.  Benlysta is teamed up with Glaxo SmithKline and if approved Human Genome Sciences will share marketing costs and profits.  The expected market is anywhere between 1-3 Billion.

I think the benefits for the drug outweigh any concerns and it could be approved December 9th by the FDA.  With that being said though, the FDA has rejected a lot of drugs this year and is very conservative.  There are some concerns and more clinical trials could be advised before approval.  We will have to see.  Today's FDA review notes had concerns with the drug's suicide rate and it's efficacy for African-Americans, who are more likely to have Lupus.  The concerns dropped the stock and has investors spooked, but I still think that it will be recommended.  I hope I am not wrong on this one. 

For more information about Human Genome Sciences visit their website HGSI.com. 

Learn more about Lupus (SLE), please visit their website at Lupus.org.

Wikinvest--Human Genome Sciences (HGSI)

Wikinvest--Glaxo (GSK)

Yahoo Finance--HGSI

Yahoo Finance--GSK

For more on Tuesday's Decision

Compugen, The Future of Drug Discovery

Here is some really good analysis on the Future of Drug Discovery. Computerized Genetic Analysis for targeted therapeutics using Comugen's technology. It is a very complex system that doesn't have a guarantee for success but it is changing the way pharmaceutical and biotech companies research innovative new drugs. Currently, Zacks has a #1 Strong Buy Ranking on Compugen (CGEN).  Visit their website at www.cgen.com.


Compugen collaborates with many companies and is poised for a breakout with a future blockbuster drug discovery, which would give them royalty payments for their innovation. Find out more about Compugen's collaborative partners here, some notable companies include Pfizer, Roche, Teva, and Merck.

Compugen Licenses Novel Oncology Target to Seattle Genetics

Agreement provides Seattle Genetics with research license and option for exclusive commercial license to monoclonal antibody-based therapeutics targeting Compugen-discovered target

Existence of target initially predicted in silico using Compugen’s Monoclonal Antibody Targets Discovery Platform

Inhibitex Has Two Upcoming Catalyst Events

Image via Wikipedia

Today we will examine Inhibitex.  Here is Inhibitex's website and Yahoo Finance's Profile:  INHX.

Inhibitex has 2 upcoming catalysts and is recommended by Zacks Research.  Extensive Recommendations by Zacks can be found in the two articles below.  Find out more Research Tools from Zacks at their website Zacks.com.

Inhibitex Pipeline Moves Forward
Buy Inhibitex Ahead of Big Catalysts

A Call for a Stock Double (INHX)

Searching for the Next Dendreon, Biovest's Emerging Cancer Vaccine



Image via Wikipedia

Non-Hodgkins Lymphoma Cell

I am always on the hunt for the next Dendreon.  Previously, I have mentioned Arqule in my article,  Is Arqule the next Dendreon?  Now possibly the future Cancer Vaccine maker, Biovest (BVTI).  Here is a news article that discusses the next possible cancer vaccine to follow Dendreon's Provenge.  Biovest is in clinical trials for Non-Hodgkins Lymphoma with BiovaxID.  Yahoo Finance  BVTI

Biovest currently is emerging from bankruptcy, so this could be a very risky trade. Read more in this Florida newspaper article titled, Accentia, Biovest prepares to leave bankruptcy.  So it will remain on my radar until things get a little better financially.

What Comes After Dendreon’s Provenge?

Patricia F. Dimond, Ph.D.
Analysis & insight: Oct 18, 2010 
 

KEYWORDS:  Cancer, Geron, Lymphoma,  Vaccines , Dendreon, Biovest, Immunotherapies, Provenge, Ovarian Cancer, AML, BiovaxID, GRNVAC1, Prima Biomed, CVac