Flex Pharma’s cramp study fails, shares plunge; FDA makes Egalet wait on pain drug

Christoph Westphal

Christoph Westphal

Shares of Flex Pharma $FLKS took a nasty hit yesterday as the biotech tried to explain away a preliminary conclusion that their lead drug, FLX-787, failed a study for preventing leg cramps. If you exclude data from one of the three sites you get a significant result, said the biotech. That argument rarely fares well, and Christoph Westphal’s company wasn’t able to make much headway against the negative reaction.

Egalet $EGLT will have to wait a bit longer before the FDA makes up its mind about its new pain med. The agency wants more time to review the application, says Egalet CEO Bob Radie, not unexpected for a therapy that billed itself as an abuse-deterrent opioid. An FDA panel voted 18 to 1 to back approval for Arymo ER (morphine sulfate). Said Radie: “The FDA indicated that they need more time as they have done with other abuse-deterrent opioid NDAs, and confirmed that no additional scientific information or data is needed for our application.”

A refugee from Novartis’s cell therapy unit, now being broken up, has landed at the small French biotech TxCell as VP of cell engineering. Li Zhou had been a lab head at Novartis, where he worked on their CAR-T programs.

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Sr. Manager, Regulatory Affairs, CMC
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