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Biotech Stock Mailbag: Ariad, NewLink, Zogenix, 5 Falling Stocks For Rest of '13


There is a twist: While we will see the drisapersen data at OTS on Oct. 8, the possibility still exists that Glaxo presents the same data at an earlier date.

Does this mean we may see the drisapersen data at the World Muscle Society meeting, which runs Oct. 1-5? Do Glaxo and Prosensa have plans to issue a press release disclosing top-line results from the drisapersen study prior to any presentation at a medical meeting?

Prosensa and Glaxo are staying mum, which is frustrating. In my view, the companies have been too opaque about their plans to present these drisapersen data. Thankfully, we don't have to wait too much longer.

On a related note:

I walked through multiple scenarios for how Sarepta Therapeutics' (SRPT) stock price may react to the drisapersen data in this August Mailbag.

Moving on.

On Tuesday, the FDA announced a safety labeling changes and post-market study requirements for companies that sell long-acting and extended release opioid painkillers.

FDA Commissioner Margaret Hamburg said the new safety requirements were meant to "to combat the crisis of misuse, abuse, addiction, overdose, and death from these potent drugs that have harmed too many patients and devastated too many families and communities."

The safety crackdown on long-acting opioids comes as FDA is still reviewing Zogenix's (ZGNX) Zohydro, an extended-release formulation of hydrocodone that doesn't contain acetaminophen. It's important to note that Zohydro has no abuse deterrent technology. Given the FDA's strong actions to crack down on the abuse of long-acting opioids, it seems completely illogical for the agency to reverse course and approve Zohydro.

I can't explain why it's taking FDA so long to issue an approval decision on Zohydro. Zogenix has been in limbo since March when FDA delayed a ruling. Most recently, the company said it expected to hear from the FDA by the end of the summer. Well, it's mid-September and still nothing.

Last December, an FDA advisory panel voted against recommending Zohydro's approval, mainly for safety reasons. After the negative vote, Zogenix shares sank to around $1.50 as investors essentially wrote off any chance of Zohydro's approval. Zogenix shares were trading at $1.88 on Thursday, suggesting the market already prices in doubts about Zohydro's approval chances.

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