Dyne Therapeutics(US:DYN) Globenewswireยท2025-05-08 11:30Core Insights - Dyne Therapeutics is advancing its lead programs DYNE-101 and DYNE-251 towards potential U.S. Accelerated Approval submissions in 2026, with possible commercial launches in 2027 [2][5] Regulatory Developments - A Type C meeting with the FDA's CDER was held in May 2025 to discuss the regulatory path for DYNE-101 in DM1, with plans for a regulatory update following the receipt of meeting minutes [1][5] - The Registrational Expansion Cohort of the ACHIEVE Trial for DYNE-101 has been initiated, aiming for full enrollment by mid-2025 and data reporting in H1 2026 to support a potential BLA submission [1][5] - The Registrational Expansion Cohort of the DELIVER Trial for DYNE-251 has been fully enrolled, with data expected in late 2025 and a potential BLA submission anticipated in early 2026 [1][5] Financial Performance - As of March 31, 2025, the company reported cash, cash equivalents, and marketable securities totaling $677.5 million, sufficient to fund operations into the second half of 2026 [7] - Research and development expenses for Q1 2025 were $106.4 million, a significant increase from $44.5 million in Q1 2024 [7][8] - General and administrative expenses decreased to $15.9 million in Q1 2025 from $24.6 million in Q1 2024 [8] - The net loss for Q1 2025 was $115.4 million, or $1.05 per share, compared to a net loss of $65.6 million, or $0.81 per share, in Q1 2024 [8][14] Leadership Changes - Dyne has strengthened its leadership team with new appointments, including Erick Lucera as CFO, Vikram Ranade as CBO, and Ranjan Batra as CSO, to support the company's late-stage clinical and commercialization plans [2][5][11]