In a surprise decision, the Food and Drug Administration said it would convene an advisory committee to discuss Sarepta Therapeutics,srpt) muscular dystrophy gene therapy, and SRPT stock fell on Friday.
Just two weeks ago, Sarepta said the FDA would not ask a panel of independent experts to weigh in on the risks and benefits of gene therapy for Duchenne muscular dystrophy. But the agency changed its mind during a late-night meeting, Sarepta said in a news release Thursday.
Sarepta is asking for accelerated approval, meaning it still hasn’t completed two Phase 3 studies of the drug SRPT-9001. But it assumes that treatments based on elevated levels of a key protein in patients work. Outside experts will debate whether the protein indicates a benefit for patients.
“While we now see the potential for greater near-term stock volatility with upcoming regulatory events, we still see many upsides for SRPT-9001,” RBC Capital Markets analyst Brian Abraham said in a note to clients.
In premarket trading at today’s stock market, SRPT stock fell 19.7% near 120.20.
More to follow.
Follow Allison Gatlin on Twitter @IBD_AGatlin,
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