DYN ALERT: Ongoing Investigation Into Dyne Therapeutics, Inc. - Contact Levi & Korsinsky
NEW YORK, NY / ACCESS Newswire / June 19, 2025 / Levi & Korsinsky notifies investors that it has commenced an investigation of Dyne Therapeutics, Inc. ("Dyne Therapeutics, Inc.") (NASDAQ:DYN) concerning possible violations of federal securities laws.
Dyne Therapeutics issued a press release on June 17, 2025, 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.
Following this news, Dyne 's stock price fell over 21% on June 17, 2025. To obtain additional information, go to:
or contact Joseph E. Levi, Esq. either via email at jlevi@levikorsinsky.com or by telephone at (212)363-7500.
WHY LEVI & KORSINSKY:Over the past 20 years, Levi & Korsinsky LLP has established itself as a nationally-recognized securities litigation firm that has secured hundreds of millions of dollars for aggrieved shareholders and built a track record of winning high-stakes cases. The firm has extensive expertise representing investors in complex securities litigation and a team of over 70 employees to serve our clients. For seven years in a row, Levi & Korsinsky has ranked in ISS Securities Class Action Services ' Top 50 Report as one of the top securities litigation firms in the United States. Attorney Advertising. Prior results do not guarantee similar outcomes.
CONTACT:
Levi & Korsinsky, LLP
Joseph E. Levi, Esq.
Ed Korsinsky, Esq.
33 Whitehall Street, 17th Floor
New York, NY 10004
jlevi@levikorsinsky.com
Tel: (212)363-7500
Fax: (212)363-7171
https://zlk.com/
SOURCE:Levi & Korsinsky, LLP
View the original press release on ACCESS Newswire
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