Is Elevidys still available?
Yes — but only for ambulatory patients aged 4 and older. Non-ambulatory patients were removed from the label in November 2025 following the deaths, and the European Medicines Agency has refused EU authorisation.
Yes, but in a narrower form. On July 28, 2025, the FDA recommended Sarepta resume shipments for ambulatory patients, after concluding that the death of an 8-year-old boy in Brazil was unrelated to the product. On November 14, 2025, a label update added a boxed warning for acute serious liver injury and acute liver failure and removed eligibility for non-ambulatory patients.
As of September 2026, Elevidys is approved only for ambulatory patients aged 4 and older, and the European Medicines Agency has refused EU authorisation. Sarepta had also announced in July 2025 that it would cut about 36% of its workforce, roughly 500 employees, as part of a restructuring.