Sarepta, FDA and gene
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Sarepta would need to conduct new analyses to validate the safety of Elevidys—which has had U.S. shipments paused by the company over a mounting string of controversies—to the FDA, Endpoints News reported Thursday, citing an unnamed senior FDA official.
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The U.S. Food and Drug Administration will request Sarepta Therapeutics to voluntarily stop all shipments of its gene therapy, Elevidys, a source familiar with the matter told Reuters on Friday. Shares of the company extended losses and were down nearly 35% in afternoon trading,
The FDA has placed multiple investigational gene therapy clinical trials on hold, signaling broader platform concerns.
The FDA will request Sarepta Therapeutics stop all shipments of Elevidys, its gene therapy for Duchenne muscular dystrophy, following two deaths tied to the product.
These were the most active stocks ahead of Friday's market open: Sarepta Therapeutics Inc.'s stock tumbled 27% after the company said another patient died following gene-therapy treatment, Bloomberg reported,
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Shares of Sarepta Therapeutics declined 16.5% to $18.32 in premarket trading on Friday after a Bloomberg report that a patient enrolled in an early-stage study of one of the company's gene therapies has died from acute liver failure.