Sarepta Therapeutics has voluntarily and temporarily halted shipments of its Duchenne muscular dystrophy gene therapy Elevidys in the US following safety concerns linked to patient deaths and escalating regulatory pressure. The pause comes after Sarepta initially resisted FDA demands to suspend distribution due to acute liver failure cases. The FDA criticized Sarepta's transparency regarding a third patient death tied to a related gene therapy and threatened to use full regulatory authority. Sarepta aims to collaborate with the FDA to complete a safety label update while maintaining communication with the Duchenne community about ongoing developments.