Shares of Dyne Therapeutics, Inc. (DYN) surged 5.37% in pre-market trading on Monday following a significant announcement regarding its lead drug candidate. The clinical-stage biotechnology company revealed 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.

The Breakthrough Therapy Designation is based on promising data from the ongoing DELIVER clinical trial. This designation is designed to expedite the development and review process of DYNE-251, offering several advantages including enhanced FDA support and accelerated review timelines. The news has sparked investor optimism about the potential of DYNE-251 as a next-generation therapy for DMD patients.

Looking ahead, Dyne Therapeutics anticipates submitting a Biologics License Application (BLA) for U.S. accelerated approval in early 2026. The company also plans to release data from the DELIVER registrational expansion cohort in late 2025. This milestone achievement underscores the potential of DYNE-251 to provide meaningful functional improvements for DMD patients and positions Dyne Therapeutics as a key player in the treatment of this rare genetic disorder.