Roche is laying additional groundwork for European regulators on its Duchenne muscular dystrophy gene therapy Elevidys (delandistrogene moxeparvovec). The company announced a further global Phase 3 trial designed to generate placebo-controlled data aimed at addressing reservations tied to the failed Embark Phase 3 study. Roche’s submission to the EMA followed the July 2025 decision framework that leaned on conditional marketing approval after a benefit-risk assessment, while requiring more comprehensive long-term data. The announced study is intended to strengthen the evidence package for the next EMA review milestone. The move signals how gene therapy developers are increasingly tailoring trial design to regulator-specific concerns rather than relying on “pathway by promise,” particularly when pivotal endpoints underperform.