NEW YORK, June 18, 2025 (GLOBE NEWSWIRE) -- Pomerantz LLP is investigating claims on behalf of investors of Dyne Therapeutics, Inc. (“Dyne” or the “Company”) (NASDAQ: DYN). Such investors are advised to contact Danielle Peyton at newaction@pomlaw.com or 646-581-9980, ext. 7980.
The investigation concerns whether Dyne and certain of its officers and/or directors have engaged in securities fraud or other unlawful business practices.
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On June 17, 2025, Dyne Therapeutics issued a press release indicating a delay in filing for U.S. Food and Drug Administration (“FDA”) approval of DYNE-101, an experimental therapy for myotonic dystrophy type 1 (“DM1”). Following a Type C meeting with the FDA’s Center for Drug Evaluation and Research in May, the Company agreed to a revised protocol for its Phase 1/2 global ACHIEVE trial for DYNE-101 in DM1, then submitted the revised protocol to the FDA in June, incorporating changes to ACHIEVE’s ongoing Registrational Expansion Cohort. Dyne had previously set a goal to complete enrollments in the cohort in mid-2025 before generating data and submitting the regulatory submission in the first half of 2026. Under its revised schedule, however, Dyne intends to complete enrollment in the cohort in the fourth quarter of 2025, seeking a data readout in mid-2026 and a potential Accelerated Approval submission in late 2026.
On this news, Dyne’s stock price fell $2.96 per share, or 21.42%, to close at $10.86 per share on June 17, 2025.
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CONTACT:
Danielle Peyton
Pomerantz LLP
dpeyton@pomlaw.com
646-581-9980 ext. 7980
