Shares of Sarepta Therapeutics (NASDAQ: SRPT) were soaring 10.4% higher as of 10:58 a.m. ET on Friday. The big gain came after the biopharmaceutical company announced that the U.S. Food and Drug Administration (FDA) had accepted Sarepta's efficacy supplement to its Biologics License Application (BLA) for Elevidys in treating Duchenne muscular dystrophy (DMD), a rare genetic disorder.

Sarepta's first objective in filing the efficacy supplement was to expand the label for Elevidys to remove any age and ambulation restrictions. The company's second objective was to flip the accelerated approval for the gene therapy to a traditional approval. It achieved both goals.

The FDA set a Prescription Drug User Fee Act (PDUFA) date of June 21, 2024, to make its approval decision. In addition, the agency confirmed it doesn't plan to convene an advisory committee to review the efficacy supplement.

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Source Fool.com