Dyne Therapeutics, Inc., a clinical-stage muscle disease company, has reported its financial results for the third quarter of 2024 and provided updates on its corporate progress. Key highlights include the FDA's clearance of the Investigational New Drug (IND) application for DYNE-101, aimed at treating myotonic dystrophy type 1 (DM1), and the enrollment of a registrational cohort for DYNE-251 in the treatment of Duchenne muscular dystrophy (DMD).
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ACHIEVE Trial of DYNE-101 in DM1: The FDA has cleared the IND application for DYNE-101, currently being evaluated in a global Phase 1/2 ACHIEVE trial. The trial, fully enrolled with 56 participants, is set to report new data in early January 2025, including safety, tolerability, and efficacy measures.
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DELIVER Trial of DYNE-251 in DMD: Following positive efficacy data and a favorable safety profile from the Phase 1/2 DELIVER trial, Dyne has begun enrolling a 20 mg/kg Q4W registrational cohort of 32 participants. The company is pursuing expedited approval pathways for DYNE-251.
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Financial Results: As of September 30, 2024, Dyne Therapeutics reported a cash position of $723.7 million, expected to fund operations into the second half of 2026. The company's net loss for the quarter was $97.1 million, compared to a net loss of $60.2 million for the same period in 2023.
Dyne Therapeutics continues to focus on advancing its clinical programs and pipeline to address the unmet needs of individuals with neuromuscular diseases, leveraging its proprietary FORCE™ platform for the development of innovative therapeutics.
