Roche laid out a new Phase III trial plan for Elevidys (delandistrogene moxeparvovec), aiming to address lingering European regulatory questions after prior trial performance issues. The company said it will run another global Phase III study to generate placebo-controlled data to support its European approval discussions. Roche’s approach targets concerns reflected in the EMA’s reservations following the Embark Phase III trial, while also building on long-term follow-up data. Sarepta markets Elevidys in the U.S., while Roche holds rights outside the U.S., creating parallel regulatory workstreams. For the gene-therapy market, the move signals continued escalation of late-stage evidence requirements for one of the category’s high-visibility products. It also reinforces how regulators are shaping expectations around robustness of benefit-risk claims for systemic gene delivery.