Roche said it will launch a new global Phase 3 trial for the Duchenne muscular dystrophy gene therapy Elevidys after Europe’s main regulator delivered a negative opinion. The company aims to generate placebo-controlled data over 72 weeks that could support a revised path to European approval. The study will enroll about 100 “early ambulatory” boys with Duchenne, randomizing them to Elevidys or placebo. Roche’s strategy reflects an attempt to address prior concerns about long-term benefit and to strengthen the clinical evidence package versus the Embark Phase 3 outcome. The development matters because Elevidys’ regulatory history has been volatile, with restrictions in the U.S. in certain patients following safety concerns. Another Phase 3 readout could determine whether the therapy can regain market access in Europe and beyond.