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.  

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

Inhibitex Has Two Upcoming Catalyst Events

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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)

Comprehensive List of Drugs Approved During the Summer 2010

I found this nice list of 2010 drug approvals on The Health Wisdom Blog.  This probably is the most informative posting on Drug Approvals from 2010.


Glaxo (GSK), Merck (MRK), Novartis (NVS), Sanofi-Aventis (SNY), and Amgen (AMGN)  were again at the top on these approvals.

New Drugs Approved Summer 2010

New drugs not only offer hope, but possibly a better quality of life, for those awaiting new treatments. However, new drug approvals can also spark controversy. The FDA approved 17 new drugs this summer (June-August 2010). Many offer new promise, and one in particular promises a great deal of future debate.

Biovail, Valeant Pharmaceuticals, GSK gain FDA recommendation for Epilepsy drug Potiga

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Today saw some good news from the FDA as they recommended the joint venture drug, Potiga, by Valeant Pharmaceuticals and Glaxo SmithKline. Valeant is in merger acquisitions with Biovail that should be completed by the year's end.

U.S. Food and Drug Administration advisory committee voted unanimously 11-0 that clinical studies had provided substantial evidence on the safety and effectiveness of ezogabine to treat epilepsy. The Prescription Drug User Fee Act goal date for the FDA to complete its review of the drug’s application is August 30. The drug will be aimed at patients whose other epilepsy medications failed.