Dyne Therapeutics Reports Third Quarter 2025 Financial Results and Recent Business Highlights

Core Insights - Dyne Therapeutics reported financial results for Q3 2025, highlighting advancements in its clinical programs for neuromuscular diseases, particularly Duchenne Muscular Dystrophy (DMD) and Myotonic Dystrophy Type 1 (DM1) [1][12] Financial Performance - Cash, cash equivalents, and marketable securities totaled $791.9 million as of September 30, 2025, an increase from $642.3 million in the previous year [12][19] - Research and development (R&D) expenses were $97.2 million for Q3 2025, up from $92.8 million in Q3 2024 [13][19] - General and administrative (G&A) expenses rose to $16.7 million in Q3 2025 from $12.9 million in Q3 2024 [15][19] - The net loss for Q3 2025 was $108.0 million, or $0.76 per share, compared to a net loss of $97.1 million, or $0.96 per share, in Q3 2024 [15][19] Clinical Development Updates - The FDA granted Breakthrough Therapy Designation to z-rostudirsen for DMD, with topline data expected in December 2025 to support a potential U.S. Accelerated Approval submission in Q2 2026 [6][9][14] - Dyne anticipates full enrollment in the Registrational Expansion Cohort of the ACHIEVE trial for z-basivarsen in DM1 by early Q2 2026, a delay from previous guidance of Q4 2025 [3][5] - The company aims to launch z-rostudirsen in Q1 2027, pending FDA approval, and z-basivarsen in Q1 2028 [7][11] Pipeline and Platform - Dyne's FORCE platform is designed to deliver multiple drug payloads effectively into muscle and the central nervous system (CNS) [2][16] - The company is developing targeted therapeutics for various neuromuscular diseases, including DMD and DM1, with additional preclinical programs for facioscapulohumeral muscular dystrophy (FSHD) and Pompe disease [16]