Roche announced a further global Phase III trial route for its Duchenne muscular dystrophy gene therapy Elevidys (delandistrogene moxeparvovec) as it seeks EMA approval progress. The company said the additional study is intended to generate new placebo-controlled evidence to address reservations connected to a prior Embark Phase III miss. Roche’s plan is designed to strengthen the benefit-risk dossier after the EMA’s July 2025 response to Embark. The company’s strategy focuses on producing more mature and directly comparable data. For DMD stakeholders, the update clarifies how gene therapy developers may need additional trials to navigate regulator-specific evidence expectations even when conditional or accelerated paths exist elsewhere.