Showing posts with label Orexigen Therapeutics. Show all posts
Showing posts with label Orexigen Therapeutics. Show all posts

10/23/10

Put Calls Anyone?

A diagram of the 9 levels of Dante's Hell.Image via Wikipedia Arena Pharmaceuticals is in a tough spot as the FDA rejects their weight loss drug lorcaserin, apparently one of the safer of the 3 up for approval.

Here is the link to investors. 

This decision was expected and predicted in my past articles on the Obesity Drug Market.  We all saw it coming.  I'm sorry if you didn't.  But expect loses for Orexigen, and Vivus with their upcoming FDA decisions.   I can only see gains made with shorting the stocks.  Those that had are sitting pretty right now.  It's a gamble but sometimes these gambles pay off.  I expect more loses to mount for these companies in the near future.  Arena Pharmaceuticals, Vivus Inc., and Orexigen Therapeutics.

What they chose to do next is anyones guess.  The technology could be sold off for further research.  And the company enters bankruptcy court.  Nonetheless just passing on the news.  I'm not always right but some are easier to pick than others.  Last weeks news of Amylin, Alkermes, and Eli Lilly and Company for their diabetes medicine was a heartbreaker for those who thought it would go the other way.  But there are always more to look at.  Keep looking forward and use it as a lesson.

Arena Pharmaceuticals Enters FDA Purgatory

Welcome to FDA purgatory, Arena Pharmaceuticals. It could be a long wait.


10/19/10

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

The four gas giants in the solar system, from ...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
More Articles

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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7/17/10

F.D.A. Panel Votes Against Obesity Drug

Image representing Orexigen Therapeutics as de...


F.D.A. Panel Votes Against Obesity Drug
By ANDREW POLLACK
Published: July 15, 2010 From the NY Times

A federal advisory committee voted narrowly against endorsing a drug vying to become the first new prescription medicine for obesity in more than a decade, signaling heightened concerns for possible health risks associated with a new generation of diet pills.

The advisory committee to the Food and Drug Administration voted 10 to 6 that the safety concerns, like increased heart rate, possible birth defects and psychiatric problems, overrode the potential benefits of the drug, called Qnexa and developed by Vivus.