Roche said it is escalating its push for EMA approval of its Duchenne muscular dystrophy gene therapy, Elevidys (delandistrogene moxeparvovec), by announcing a further global Phase 3 trial. The company is seeking additional placebo-controlled data after prior EMA reservations tied to the Embark Phase 3 readout. Roche’s plan is intended to address the agency’s concerns raised in the July 2025 ruling after Embark did not meet its primary endpoint. The updated Phase 3 program is meant to generate broader evidence through new data collection and inform the long-term follow-up picture. The update matters for DMD developers because it signals how sponsors may respond to regulator feedback—through additional randomized data designed to tighten benefit-risk assessments—rather than relying solely on previously submitted files.