Roche moved to restart Europe-focused evidence for Duchenne muscular dystrophy gene therapy Elevidys by announcing a new global phase III trial. The study is designed to generate additional placebo-controlled data after Europe’s regulator previously issued a negative opinion following the Embark phase III readout. Roche said the trial will enroll about 100 early-ambulatory boys and randomize them to Elevidys or placebo, with the primary endpoint centered on “time to rise” over 72 weeks. The announcement aims to support a reworked regulatory submission and address EMA reservations tied to the therapy’s long-term functional benefits. Elevidys has faced additional scrutiny in the U.S., including restrictions after safety controversy and mixed trial outcomes. Roche’s decision to pursue another phase III effort signals continued willingness to invest in the gene therapy’s clinical case for European patients and regulators.