StockNews.AI
DYN
StockNews.AI
62 days

INVESTOR ALERT: Pomerantz Law Firm Investigates Claims On Behalf of Investors of Dyne Therapeutics, Inc. - DYN

1. Dyne Therapeutics faces an investigation for potential securities fraud. 2. FDA approval for DYNE-101 is delayed, impacting trial timelines. 3. Stock price dropped by 21.42% following the delays and investigation news. 4. Revised enrollment schedule now targets late 2025 with a data readout in mid-2026. 5. Investors are advised to contact Pomerantz LLP for possible class action involvement.

4m saved
Insight
Article

FAQ

Why Very Bearish?

The significant price drop and investigation signal severe investor concern, reminiscent of past failures in biotech approvals.

How important is it?

The article highlights critical issues directly affecting DYN's operations and investor trust.

Why Long Term?

Delays in FDA approval and ongoing investigations could harm long-term investor confidence and potential revenue timelines.

Related Companies

VRTXPTCTREGN
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.  [Click here for information about joining the class action] 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. Pomerantz LLP, with offices in New York, Chicago, Los Angeles, London, Paris, and Tel Aviv, is acknowledged as one of the premier firms in the areas of corporate, securities, and antitrust class litigation. Founded by the late Abraham L. Pomerantz, known as the dean of the class action bar, Pomerantz pioneered the field of securities class actions. Today, more than 85 years later, Pomerantz continues in the tradition he established, fighting for the rights of the victims of securities fraud, breaches of fiduciary duty, and corporate misconduct. The Firm has recovered numerous multimillion-dollar damages awards on behalf of class members. See www.pomlaw.com. Attorney advertising. Prior results do not guarantee similar outcomes.    CONTACT:Danielle PeytonPomerantz LLPdpeyton@pomlaw.com646-581-9980 ext. 7980

Related News