What deaths have been linked to Elevidys?
Three patients died from acute liver failure — two non-ambulatory DMD boys in March and June 2025, and a 51-year-old man in a related Sarepta gene therapy trial using the same AAVrh74 vector — prompting holds and boxed-warning requirements.
The first reported death, from acute liver failure in a non-ambulatory patient, was announced on March 18, 2025. A second non-ambulatory patient died from acute liver failure in June 2025, after which Sarepta paused dosing of non-ambulatory patients and its confirmatory ENVISION trial. The FDA said it was investigating both deaths. In July 2025 a 51-year-old man in a trial of a related Sarepta therapy, SRP-9004, which uses the same vector, also died of liver failure. Separately, an 8-year-old boy treated in Brazil died in June 2025; Brazilian regulators and later the FDA concluded that death was unrelated to Elevidys, with a CNBC reporter noting that Brazilian regulators had determined the boy likely died from flu intensified by immunosuppression.