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

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.

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For more on Tuesday's Decision