Sarepta launched a second Phase 3 trial for Elevidys (SRP-5053), aiming to address the EMA’s marketing authorization denial after the EMBARK evidence package fell short on efficacy in movement abilities at 12 months. Roche, Sarepta’s partner, will oversee the new registration-enabling study. The program targets regulator-identified gaps with additional placebo-controlled efficacy and safety data over 72 weeks. Elevidys remains FDA-approved in the US, leaving Europe with a renewed regulatory path that will depend on whether this new dataset closes the EMA’s threshold for benefit and safety.