Roche has temporarily halted shipments of Elevidys, a Duchenne muscular dystrophy gene therapy marketed outside the United States, amid mounting safety concerns including liver injuries linked to fatalities. Supply will continue for countries with independent regulatory approvals. The move follows Sarepta’s voluntary pause of Elevidys shipments in the U.S. Regulatory scrutiny over safety data challenges the gene therapy’s market availability, with Roche and Sarepta navigating an evolving and difficult regulatory environment for the treatment.