Sarepta has launched a new Phase 3 trial for Elevidys (delandistrogene moxeparvovec) to address concerns raised by the European Medicines Agency. EMA denied marketing authorization after Elevidys missed efficacy endpoints in the initial evidence package from Sarepta’s Phase 3 EMBARK program. Roche, which partners with Sarepta on Elevidys outside the U.S., will oversee the new registration-enabling study. The updated trial plan is designed to generate additional placebo-controlled efficacy and safety data over 72 weeks in response to EMA’s regulatory requirements. The launch underscores how even FDA approval does not automatically translate to global access, and how post-hoc evidence generation can become the critical path for rare disease gene therapies in Europe.