Sarepta +11.2% following FDA statement
- Four days after getting crushed on news the FDA wants additional data on its eteplirsen muscular dystrophy drug, Sarepta (NASDAQ:SRPT) is bouncing in response to an FDA statement clarifying its stance.
- The FDA notes its concerns that "the methods used to measure [muscle protein] dystrophin were not adequately robust to support an NDA submission" for eteplirsen, and that it "provided Sarepta with detailed recommendations on how to improve these dystrophin analyses."
- However, it also says it's willing to conduct a "rolling review" of Sarepta's NDA, and that it will "present the NDA for eteplirsen to a public advisory committee meeting before making a decision on approval." The agency adds it will "continue to work with Sarepta in their efforts to provide the data it considers critical to FDA’s ability to review the NDA."
- Oppenheimer thinks shares will now recover to the ~$20 range.
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