Key October FDA Catalysts - Part Two Print E-mail
By Patrick Crutcher   
Tuesday, 28 September 2010 00:00
The summer has come to an end, and so has the market slump that came with it. Stocks are on track to close September with the biggest monthly gains in over a year. Such is the word from a CNN Money report published last Friday. According to the network, the Dow has rallied 8.4% this month, which would be the best monthly gain since July 2009, when the blue-chip index added 8.6%. The latest lift also puts the Dow on track for its best September since 1939, when it rose 13.5%. The S&P has rallied 9.5%, the largest increase since April 2009, and the Nasdaq has surged 12.6%, the biggest jump since October 2002.

Last week, stocks rose more than 2% after the major indexes broke above key technical levels early in the week. That encouraged investors to keep the momentum going, and stocks ended with a rally to fresh four-month highs.

Without getting into too much detail, we want to follow up part one of this report and briefly mention some of the other notable big decisions that are coming up in October. Be sure to mark your calendars for these fireworks! We'll have more coverage and analysis of these stocks in the weeks ahead.

Human-Genome Sciences Inc.(NASDAQ:HGSI) has a FDA decision on 10/04/10(Monday) HGSI for their NDA for ZALBIN™ (albinterferon alfa-2b, known in Europe as JOULFERON®) dosed every two weeks for the treatment of chronic hepatitis C.  Zalbin is partnered with Novartis(NVS). HGSI does not expect approval at this time based on preliminary discussions with the FDA, in particular the FDA has concerns over the risk benefit assessment of Zalbin. In April 2010, HGS announced that Novartis withdrew its Marketing Authorization Application for JOULFERON from the European Medicines Agency.

Don’t forget that HGSI has an all important FDA review panel on 11/16/10(Tuesday) and  PDUFA date of 12/9/10(Thursday) for BENLYSTA®(belimumab) as a potential treatment for systemic lupus erythematosus (SLE). HGSI has an equal profit-sharing agreement with GSK for BENLYSTA. Look out for the panel documents a few days before hand. A positive panel vote would certainly send shares higher, as would approval. BENLYSTA has multi-billion dollar potential. HGSI has been seen as a likely M&A target by GlaxoSmithKline(GSK), their partner on Benlysta, darapladib and Syncria. For more information, see our article below.

Notes on HGSI rumors:

ISTA Pharmaceuticals Inc. (NASDAQ: ISTA) has a PDUFA date of 10/16/10(Saturday) for the sNDA for developing a once-daily version of Xibrom, or XiDay, for the treatment of ocular inflammation and pain following cataract surgery. ISTA forecasts sales from its Xibrom franchise to be in the around $100M.

Arena Pharmaceuticals Inc.(NASDAQ:ARNA) has a PDUFA date of 10/22/10(Friday) for Lorquess(lorcaserin), for the treatment of obesity and weight-loss. ARNA received a negative vote of approval during the FDA panel review on 9/16/10. Approval seems unlikely at this point given safety concerns surrounding Lorquess.

VIVUS Inc.(NASDAQ:VVUS) has a PDUFA date of 10/28/10(Thursday) for Qnexa, for the treatment of obesity. VVUS received a negative vote of approval during the FDA panel review on 7/15/10. Approval seems unlikely at this point and it’s unclear how much their 2-year data will help. Notably, Qnexa showed the most promise out of all the obesity drugs, in terms of efficacy.

Biodel Inc(NASDAQ:BIOD) has a PDUFA date of 10/30/10(Saturday) for the approval of their NDA on Linjeta™, for the treatment of diabetes. Linjeta is Biodel's proprietary formulation of recombinant human insulin that is designed to be absorbed into the blood faster than currently marketed rapid-acting insulin analogs. Approval would certainly send this small biotech skyward.

October is looking to be a pretty big month in biotech! Smart moves in October could certainly be very rewarding. Make sure to be thorough in your review of any company, especially with such important decisions coming soon that could radically effect the price. We will keep you updated.


Disclosure: No Positions

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