Roche said it will run another Phase 3 trial of Duchenne muscular dystrophy gene therapy Elevidys aimed at supporting European approval after the European regulators issued a negative review last year. The company’s plan is to generate long-term evidence that could support a resubmission with European officials. The Phase 3 study will compare Elevidys versus placebo over 72 weeks in roughly 100 boys in early disease stages. Roche said it also intends to use the new dataset to support regulatory applications beyond Europe. Elevidys is developed by Sarepta Therapeutics, while Roche holds rights outside the US where the therapy is marketed, setting up parallel regulatory strategies depending on region-specific evidence standards.