Roche announced a new global Phase 3 trial for Duchenne muscular dystrophy gene therapy Elevidys as it tries again for European approval after prior negative European Medicines Agency feedback. The follow-up study will enroll about 100 early ambulatory boys and randomize them to Elevidys or placebo over 72 weeks. The trial’s primary endpoint focuses on meaningful change in “time to rise,” an ability measure that Roche says is an important predictor of disease progression. The update comes after earlier testing in Europe failed to show a meaningful motor function benefit, and after Elevidys faced setbacks including restrictions in the U.S. tied to safety controversies. For Sarepta-developed therapy, the new trial underscores how regulators can drive new evidence requirements even after initial approvals. It also signals that Roche intends to generate resubmission-ready data rather than pursue incremental changes to existing submissions.