Sarepta launched a second Phase III clinical trial for Elevidys (delandistrogene moxeparvovec) aimed at addressing European Medicines Agency concerns. EMA previously denied marketing authorization after EMBARK did not meet efficacy endpoints, citing insufficient evidence of clinical benefit on movement abilities at 12 months. The new registration-enabling trial is designed to generate additional placebo-controlled efficacy and safety data over 72 weeks, with Roche overseeing the study as Sarepta’s licensing partner. Sarepta and Roche plan enrollment quickly, with primary data expected in future years. The update underscores the split pathway between FDA approval and EMA requirements for DMD, especially as the program navigates prior safety events that prompted shipment pauses and dosing suspensions during clinical and commercial use.