FDA Ends October With Drug Approvals
BOSTON (TheStreet) -- U.S. regulators ended October with two drug approvals, clearing an antibiotic from Forest Labs(FRX_) and a first-time treatment for a neurological disorder developed by Avanir Pharmaceuticals(AVNR).
Investors are still waiting on the fate of Biodel's (BIOD) fast-acting insulin Linjeta. The U.S. Food and Drug Administration was expected to issue an approval decision Friday, but the news could come Monday.
October was a busy but tough month for new drug approvals at the FDA. Regulators rejected seven new drugs, including a diabetes drug from Amylin Pharmaceuticals (AMLN) and weight-loss drugs from Arena Pharmaceuticals (ARNA) and Vivus (VVUS), respectively.
The FDA approved four drugs: the two mentioned above plus drugs from Questcor Pharmaceuticals(QCOR) and Alkermes (ALKS).
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The Forest Labs (FRX) injectable antibiotic Teflaro approved Friday will be used to treat patients with pneumonia and bacterial skin infections, including methicillin-resistant Staphylococcus aureu, or MRSA.
Showing posts with label Amylin Pharmaceuticals. Show all posts
Showing posts with label Amylin Pharmaceuticals. Show all posts
10/31/10
10/24/10
Jim Cramer Makes Mistakes Too
Image by Michael McDonough via FlickrJim Cramer apologizes for his mistakes. Jim Cramer isn't always right on his calls so just take that in mind when you watch Mad Money. But the guy is entertaining And sometimes he is right and sometimes he is wrong. I too didn't see this decision by the FDA happening and apologize myself but I only liked Alkermes as a trade and still think it is a buy right now. Alkermes symbol ALKS. Eli Lilly (LLY) also posted strong 3Q earnings and was up Friday. 4 Rules for Trading Biotech Spec Stocks
Two stocks that Cramer recommended last Thursday, Oct. 14 got crushed this week after an expected Food & Drug Administration approval never happened.
Everyone, including the “Mad Money” host, assumed regulators would bless a new diabetes medication being made by Amylin [AMLN 11.30 -0.18 (-1.57%) ] and Alkermes [ALKS 11.07 -0.03 (-0.27%) ]. But when the FDA on Tuesday requested more data rather than approving the drug, their share prices plummeted 50 percent and 30 percent, respectively.
So where did Cramer, and even the most negative of analysts, go wrong? What lessons has he learned from this week? He broke them down into four takeaways for any investors considering a little biotech speculation going forward. Watch the video 4 Rules For Trading Biotech for his full report.
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10/20/10
The Short-Seller Who Got Amylin Right
Image via WikipediaNEW YORK (TheStreet) -- Not all investors are shocked and upset about the decision by U.S. regulators to reject Amylin Pharmaceuticals' (AMLN) diabetes drug Bydureon. Short-sellers -- investors who bet that Amylin shares would fall -- are positively giddy and making money. Amylin shares are down $10.35, or 50%, to $10.14 in Wednesday trading.
How did the shorts get Amylin right when a majority of investors believed Bydureon was going to be approved? I spoke with one Amylin short early Wednesday about his bear thesis. This hedge fund manager asked to remain anonymous because the rules of his fund forbid him to speak publicly about his investments.
"I always believed that Amylin and Eli Lilly (LLY) were taking shortcuts to get Bydureon through the FDA" and the agency was going to have problems with this approach, said this short seller.
10/19/10
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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