Sarepta launched an additional Phase III trial for its Duchenne muscular dystrophy gene therapy Elevidys to address prior European Medicines Agency marketing authorization concerns. The move follows the EMA’s denial after the EMBARK evidence package and reported efficacy gaps in movement abilities at 12 months. Roche, Sarepta’s licensed partner, will oversee the registration-enabling study. The plan is designed to generate additional placebo-controlled efficacy and safety data over 72 weeks to meet EMA requirements. Sarepta’s filing comes after earlier safety and regulatory complications, including a prior FDA-requested shipment halt tied to liver failure deaths in non-ambulatory patients, underscoring the stakes for the resubmission pathway.