Business
Dyne Therapeutics Reports First Quarter 2025 Financial Results and Recent Business Highlights
- FDA (CDER) Type C meeting held in May 2025 for DYNE-101 in DM1 and Dyne plans to provide a regulatory update following receipt of meeting minutes - -
About this update from Dyne Therapeutics, Inc.
[{"type":"text","content":"- FDA (CDER) Type C meeting held in May 2025 for DYNE-101 in DM1 and Dyne plans to provide a regulatory update following receipt of meeting minutes - - Registrational Expansion Cohort of ACHIEVE Trial of DYNE-101 in DM1 initiated to support potential submission for U.S. Accelerated Approval in H1 2026 - - Registrational Expansion Cohort of DELIVER Trial of DYNE-251 in DMD fully enrolled to support potential submission for U.S. Accelerated Approval in early 2026 - WALTHAM, Mass., May 08, 2025 (GLOBE NEWSWIRE) -- Dyne Therapeutics, Inc. (Nasdaq: DYN), a clinical-stage company focused on advancing life-transforming therapeutics for people living with genetically driven neuromuscular diseases, today reported financial results for the first quarter of 2025 and recent business highlights. “Our two lead programs continue to demonstrate compelling and favorable data, including evidence of functional improvement across multiple measures in DM1 and DMD. We are urgently advancing both programs toward potential U.S. Accelerated Approval submissions in 2026 and possible commercial launches in 2027,” said John Cox, president and chief executive officer of Dyne. “I am also thrilled to welcome Erick, Vik and Ron to the Dyne leadership team, which now includes a new role for Oxana as chief innovation officer. Together, our team has the proven experience and capabilities to efficiently drive the business, deliver therapies that bring functional improvement and create significant shareholder value.” DYNE-101 in DM1 Dyne participated in a Type C meeting with the Center for Drug Evaluation and Research (CDER) at the Food and Drug Administration (FDA) in May 2025 and discussed the path to regulatory approval, including U.S. Accelerated Approval, for DYNE-101 in DM1.Dyne has initiated a global placebo-controlled Registrational Expansion Cohort in the ACHIEVE trial that will include up to 48 participants with full enrollment planned for mid-2025. Data from this cohort is planned for H1 2026 to support a potential U.S. Accelerated Approval Biologics License Application (BLA) submission in H1 2026. Dyne also continues to advance preparations for a Phase 3 trial with the goal of initiating the trial in 2025.Management plans to provide a regulatory update for DYNE-101 following receipt of final FDA meeting minutes and the company’s incorporation of regulat...