Alkermes Gains FDA Approval For Vivitrol, Anticipating Oct 22 Approval with Amylin Pharmaceuticals

Image via CrunchBase

Again another winning prediction from my FDA calendar for October.  Expect large gains for Alkermes tomorrow.  I wouldn't sell the stock as they have another approval up on Oct. 22nd in conjunction with Amylin and Eli Lilly for Bydureon, a weekly injectible diabetes medication.  I expect a FDA approval for that one too.  But you never know with the FDA.  Amylin already has approvals for daily injections but has modified the technology for weekly injections, so again I anticipate its approval as well.  Good news for Alkermes.

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 Alkermes addiction drug wins wider U.S. approval

Tue Oct 12, 2010 7:26pm EDT

* Vivitrol already used in U.S. for alcoholics
* Approval may help turn around money-losing drug
* Shares up nearly 69 percent in 2010
* Shares up another 4.2 percent after hours

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.

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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.