Dyne Therapeutics reported a positive pivotal trial in Duchenne muscular dystrophy, meeting the study’s primary endpoint and positioning the company to seek accelerated approval from the FDA. The company announced results that met prespecified efficacy measures in the pivotal study and stated plans to file for regulatory clearance based on the data. Executives framed the result as a potential next‑generation exon‑skipping therapy with improved clinical effect versus prior approvals; the program enters regulatory discussions with submission planning underway. The outcome triggered immediate investor and competitor attention in the DMD space, where Sarepta and others hold marketed assets and ongoing development programs. Regulators, clinicians and patient groups will scrutinize dystrophin production, functional outcomes and long‑term benefit; Dyne’s next steps will include submission logistics, labeling negotiations and post‑market evidence commitments.