Dyne Therapeutics(US:DYN) Globenewswire·2025-02-27 12:30Core Insights - Dyne Therapeutics has received FDA Fast Track Designation for DYNE-101 for the treatment of myotonic dystrophy type 1 (DM1) [7] - The company plans to fully enroll the Registrational Expansion Cohort of the ACHIEVE Trial for DYNE-101 by mid-2025 to support a submission for U.S. Accelerated Approval [1][7] - Dyne anticipates completing enrollment for the Registrational Expansion Cohort of the DELIVER Trial for DYNE-251 in Duchenne muscular dystrophy (DMD) by Q1 2025, with data expected in late 2025 [1][7] Financial Performance - As of December 31, 2024, the company reported cash, cash equivalents, and marketable securities totaling $642.3 million [5] - The company incurred R&D expenses of $81.8 million for Q4 2024, up from $58.8 million in Q4 2023, and $281.4 million for the full year 2024, compared to $210.8 million in 2023 [6][14] - General and administrative expenses for Q4 2024 were $15.3 million, compared to $8.8 million in Q4 2023, and $62.5 million for the full year 2024, up from $31.4 million in 2023 [6][14] Net Loss - The net loss for Q4 2024 was $89.5 million, or $0.88 per share, compared to a net loss of $66.6 million, or $1.09 per share, in Q4 2023 [9][14] - For the full year 2024, the net loss was $317.4 million, or $3.37 per share, compared to a net loss of $235.9 million, or $3.95 per share, in 2023 [9][14] Business Strategy - The company is focused on advancing therapeutics for genetically driven neuromuscular diseases, leveraging its FORCE™ platform [10] - Dyne is pursuing expedited approval pathways globally for both DYNE-101 and DYNE-251 [7]