Sarepta Therapeutics Inc.’s stock
SRPT,
soared 30% premarket Monday, after a U.S. Food and Drug Administration panel voted 8-6 in favor of accelerated approval for the company’s latest gene therapy for Duchenne muscular dystrophy. The vote came late Friday, despite questions about the therapy called SRP-9001’s clinical benefit and safety. . Earlier this week, the FDA said Sarepta did not offer “unambiguous evidence” the therapy will benefit patients with the deadly muscle-wasting disease. Sarepta, which hopes to gain fast-track approval via the FDA based on limited current data, is conducting a late-stage trial to confirm the therapy’s benefits to patients. The first batch of data from the trial is expected by December; full results should be available in early 2024.The FDA is expected to make a decision by May 29. The agency usually mirrors the advice of its advisers, though it is not obligated. Oppenheimer analysts, who have an outperform rating on Sarepta stock, said the vote was closer than they expected and noted the discussion was not as positive as they thought among academics, practicing doctors and FDA members. “Overall, the AdCom settled to take a holistic approach in evaluating the data on hand and the discussion leaned forward to give the DMD community a chance. We stay bullish,” they wrote in a note to clients. Sarepta stock has gained 82% in the last 12 months, while the S&P 500
SPX,
has gained 2.5%.
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