Roche outlined a new strategy to support EMA approval for Elevidys (delandistrogene moxeparvovec), signaling it will pursue additional global Phase 3 evidence for Duchenne muscular dystrophy. The company said the next trial is intended to generate placebo-controlled data designed to address prior EMA reservations. The move is tied to the Embark Phase 3 program, which missed a primary endpoint. Roche previously submitted to the EMA seeking conditional approval based on a benefit-risk argument and commitments to extend the evidence package through longer-term follow-up. In this updated plan, Roche’s near-term objective is to convert the agency’s remaining questions into decision-ready endpoints that can strengthen the overall approval case. The clinical development focus is therefore shifting to what regulators will accept as sufficient evidence for both efficacy and interpretability. For biotech stakeholders, this is another example of how regulators can effectively reshape gene-therapy development timelines, forcing sponsors to generate new trial designs rather than rely solely on earlier datasets.