Sarepta Therapeutics has reversed its prior stance and agreed to voluntarily pause shipments of Elevidys, its gene therapy for Duchenne muscular dystrophy (DMD), following FDA requests tied to patient deaths due to acute liver failure. The pause affects all U.S. shipments and aims to facilitate safety labeling updates and regulatory dialogue. The controversy follows the deaths of three patients linked to Sarepta’s and related gene therapies. Stakeholders fear disruption to patient access while regulatory scrutiny intensifies. The FDA has threatened more severe actions if Sarepta does not comply.