Roche outlined a route to EMA approval for its Duchenne muscular dystrophy gene therapy Elevidys (delandistrogene moxeparvovec) by announcing a further global Phase 3 trial. The study is intended to generate additional placebo-controlled data to address EMA reservations following the failed Embark Phase 3 primary endpoint. Roche previously submitted to the EMA seeking conditional marketing approval based on a positive benefit-risk balance, while committing to more comprehensive long-term follow-up evidence. The new Phase 3 adds another data-generation milestone in a DMD regulatory saga where endpoints, durability, and comparability remain central for European review decisions.