In a surprise decision, the Food and Drug Administration said it would hold an advisory committee to discuss Sarepta Therapeutics‘ (SRPT) muscular dystrophy gene therapy, and SRPT stock tanked Friday.
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Just two weeks ago, Sarepta said the FDA wouldn’t ask a panel of independent experts to weigh in on the risks and benefits of its gene therapy for Duchenne muscular dystrophy. But the agency changed its mind during a late-cycle meeting, Sarepta said in a news release Thursday.
Sarepta is asking for an accelerated approval, meaning it still hasn’t finished two Phase 3 studies of the drug, SRPT-9001. But it believes the treatment works based on elevated levels of a key protein in the patients. The outside experts will likely debate whether that protein signals a benefit for patients.
“While we now see more near-term stock volatility potential with upcoming regulatory events, we still see many path for SRPT-9001 to ultimately get over the line,” RBC Capital Markets analyst Brian Abrahams said in a note to clients.
In premarket trading on today’s stock market, SRPT stock crashed 19.7% near 120.20.
More to follow.
Follow Allison Gatlin on Twitter at @IBD_AGatlin.
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Source: https://www.investors.com/news/technology/srpt-stock-crashes-on-an-unexpected-roadblock-for-its-gene-therapy/?src=A00220&yptr=yahoo