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Fly News Breaks for April 21, 2016
SRPT
Apr 21, 2016 | 09:05 EDT
After this morning's updated briefing documents ahead of Monday's FDA advisory panel, Piper Jaffray analyst Edward Tenthoff says the FDA looks set to reject Sarepta Therapeutics' eteplirsen. Despite increased pressure from the Duchenne muscular dystrophy community, the FDA remains "steadfast in its skeptical view of the eteplirsen application because of a marked lack of efficacy," Tenthoff tells investors in a research note. He points out the agency used its executive summary of the briefing documents to reject Sarepta's claims of "inaccuracies" in the original agency analysis. "Tellingly, there are no voting questions, and the final discussion point concerns appropriate design of potential future trials," Tenthoff writes. He keeps a Neutral rating on Sarepta with a $15 price target. The stock is down 36%, or $7.10, to $12.61 in pre-market trading.
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