Roche will run a new global Phase 3 trial for Sarepta Therapeutics’ Duchenne muscular dystrophy gene therapy Elevidys as it seeks a path to approval in Europe. This follows a negative European Medicines Agency opinion in 2025 and mixed signals in U.S. data, which has left Elevidys under intensified scrutiny. The Phase 3 program will enroll about 100 “early ambulatory” boys, randomizing participants to Elevidys or placebo over roughly 72 weeks. Roche said the trial is designed to generate evidence that could support an updated submission and address earlier regulator concerns about meaningful motor function benefit. Elevidys has also faced U.S. safety complications tied to adverse events, leading to restrictions on use. The new trial is therefore positioned as both a clinical and regulatory reset for a flagship gene therapy already approved in multiple countries.