Why the FDA Won't Approve Lorcaserin and Qnexa (Yet)

Hot Air Images via WikipediaI don't see much hope for Arena Pharmaceuticals, Vivus, or Orexigen at gaining FDA approval at this time.  I see it as a bunch of hot air and will not be approved with this conservative FDA panel right now.  That's not to say a CRL is necessarily a bad thing but at what point does the funding run dry?  Shorting these stocks wouldn't be a bad idea.  Especially, Vivus and Orexigen.  At a lofty 5 and 6 points it won't take much time to take the plunge to 2.

Wikinvest--ARNA, VVUS, OREX

By Brian Orelli
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October 19, 2010
 
After months of speculation and a pair of Food and Drug Administration advisory panels, FDA decisions for Arena Pharmaceuticals' (Nasdaq: ARNA) lorcaserin and VIVUS' (Nasdaq: VVUS) Qnexa are finally upon us.

Arena's PDUFA date is Oct. 22, while VIVUS' date with destiny is six days later on the 28th. The Prescription Drug User Fee Act (PDUFA) sets the goal for the FDA to make a decision by then, but the FDA is free to make a decision at any point before or after that date. A decision on lorcaserin especially could be delayed since the FDA advisory panel met just last month.

What's the chance of lorcaserin and Qnexa gaining FDA approval? I'd put it somewhere between unlikely and nonexistent.

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Alkermes Gains FDA Recommendation For Vititrol

Cover of The Treatment of Opioid Dependence I expect a huge day tomorrow for Alkermes with the FDA recommendation of Vivitrol. PFUDA is Oct. 12, 2010. I expect approval with Vivotrol but you can never be sure with the FDA. Again big day tomorrow for Alkermes.

Wikinvest---Alkermes (ALKS)

Alkermes Announces FDA Advisory Committee Recommends Approval Of VIVITROL® For Opioid Dependence

Alkermes, Inc. (NASDAQ: ALKS) today announced that the U.S. Food and Drug Administration (FDA) Psychopharmacologic Drugs Advisory Committee voted 12 to 1 that VIVITROL ^® (naltrexone for extended-release injectable suspension) should be approved for the treatment of opioid dependence. Alkermes, Inc. (NASDAQ: ALKS) today announced that the U.S. Food and Drug Administration (FDA) Psychopharmacologic Drugs Advisory Committee voted 12 to 1 that VIVITROL ^® (naltrexone for extended-release injectable suspension) should be approved for the treatment of opioid dependence.

Alexza Pharmaceuticals Oct 11th FDA Decision for Staccato Technology

Image via Wikipedia Time to start buying more shares of Alexza Pharmaceuticals (ALXA). Another promising run-up play for October is Alexza Pharmaceuticals and its lead candidate AZ-004, which is an inhalation product candidate for the rapid treatment of agitation in patients with schizophrenia or bi-polar disorder. It has a PDUFA(FDA Decision) date of October 11th, 2010.

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

Image via Wikipedia

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.