Dyne Therapeutics Inc., a clinical-stage company focused on genetically driven neuromuscular diseases, has announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation to DYNE-251 for the treatment of Duchenne muscular dystrophy (DMD) patients amenable to exon 51 skipping. This designation is based on promising data from the ongoing DELIVER clinical trial and aims to expedite the development and review process of DYNE-251. The designation offers several advantages, including enhanced FDA support and accelerated review timelines. Dyne anticipates potential Biologics License Application $(BLA.AU)$ submission for U.S. accelerated approval in early 2026, with additional approval pathways being pursued outside the U.S. This achievement underscores DYNE-251's potential as a next-generation therapy with meaningful functional improvements for DMD patients.