Sarepta Therapeutics Inc.’s stock soared 30% premarket Monday, after a U.S. Food and Drug Administration panel voted 8-6 in favor of accelerated approval for...
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.
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.
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