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BioWorld - Friday, May 8, 2026
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Home » Sarepta yields to FDA request, pauses Elevidys shipments
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Sarepta yields to FDA request, pauses Elevidys shipments

July 22, 2025
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In an about-face, Sarepta Therapeutics Inc. said it would “voluntarily and temporarily” pause all shipments of Duchenne muscular dystrophy gene therapy Elevidys (delandistrogene moxeparvovec) in the U.S. The move comes only a few days after the firm publicly declined a U.S. FDA request to halt shipping of the therapy in the wake of a third patient death, this one linked to a gene therapy using the same adeno-associated virus (AAV) vector as Elevidys.
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