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

Alexza Pharma Clears Hurdles Towards Approval for Agitation Drug

Image via CrunchBase Alexza Pharma Clears Hurdles Towards Approval for Agitation Drug

I have actually changed positions on this stock and do not think it will be approved based on a conservative FDA panel under the Obama Administration.  I might change that opinion but we will have to see on This Weeks FDA panel meeting.
About the author: Sheff Station Sheff is a trader and investor of big board, small cap, and biotech stocks.

FDA staff: Jazz drug works, risk plan an issue

By Lisa Richwine

WASHINGTON | Wed Aug 18, 2010 11:23am EDT

(Reuters) - U.S. drug reviewers said a Jazz Pharmaceuticals Inc medicine helped patients with the pain disorder fibromyalgia, sending shares up 14 percent Wednesday on hopes an approval could sharply boost the company's sales.

Food and Drug Administration staff said the drug, sodium oxybate or JZP-6, was effective. But they also questioned if the company's proposed safeguards would adequately prevent improper use. The medicine contains an ingredient notoriously abused as a "date rape" drug.