Sarepta Therapeutics Inc. announced that the company plans to temporarily pause all shipments of its gene therapy to treat Duchenne muscular dystrophy, Elevidys, in a reversal of its prior stance.

Sarepta Therapeutics announces voluntary pause all shipments of Elevidys for Duchenne muscular dystrophy in US: Cambridge, Massachusetts Wednesday, July 23, 2025, 12:00 Hrs [IST]

Roche Holding AG said on Tuesday it has paused all shipments of muscular disorder gene therapy Elevidys outside the U.S., echoing a similar decision by U.S. partner Sarepta Therapeutics on Tuesday.

Sarepta CEO Doug Ingram said it is important the company maintains a “positive working relationship” with the FDA.

Roche Holding AG has temporarily halted shipments of the gene therapy Elevidys in some countries outside the U.S. following a similar move by U.S. partner Sarepta Therapeutics. The decision comes after the FDA requested a pause following the death of a patient undergoing the treatment.

The regulator had asked Sarepta Therapeutics to halt all shipments of its therapy, Ele­vidys, after three patients died from liver failure after taking it or a similar treatment.

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.