NEW YORK CITY, NY / ACCESS Newswire / June 20, 2025 / Bronstein, Gewirtz & Grossman, LLC is investigating potential claims on behalf of purchasers of Dyne Therapeutics, Inc. ("Dyne" or "the Company") (NASDAQ:DYN). Investors who purchased Dyne securities are encouraged to obtain additional information and assist the investigation by visiting the firm’s site: bgandg.com/DYN.
Investigation Details
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.
What’s Next?
If you are aware of any facts relating to this investigation or purchased Dyne securities, you can assist this investigation by visiting the firm’s site: bgandg.com/DYN. You can also contact Peretz Bronstein or his client relations manager, Nathan Miller, of Bronstein, Gewirtz & Grossman, LLC: 332-239-2660
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Contact
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Peretz Bronstein or Nathan Miller
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SOURCE: Bronstein, Gewirtz & Grossman, LLC
View the original press release on ACCESS Newswire
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