Pomerantz LLP investigates Dyne Therapeutics for potential securities fraud.

Pomerantz LLP is investigating Dyne Therapeutics for potential securities fraud. The investigation concerns Dyne's delay in filing for FDA approval of DYNE-101, an experimental therapy for myotonic dystrophy type 1. The company agreed to a revised protocol for its Phase 1/2 global ACHIEVE trial, which was submitted to the FDA in June. Investors are advised to contact Danielle Peyton for more information.

Pomerantz LLP, a renowned law firm specializing in securities class actions, has initiated an investigation into Dyne Therapeutics, Inc. (NASDAQ: DYN) regarding potential securities fraud. The investigation centers on the company's delay in filing for FDA approval of DYNE-101, an experimental therapy for myotonic dystrophy type 1 (DM1). Dyne Therapeutics agreed to a revised protocol for its Phase 1/2 global ACHIEVE trial, which was submitted to the FDA in June. Investors are advised to contact Danielle Peyton at Pomerantz LLP for more information.

On June 17, 2025, Dyne Therapeutics announced a delay in the filing for FDA approval of DYNE-101. The company had previously set a goal to complete enrollments in the ongoing Registrational Expansion Cohort by mid-2025 and submit the regulatory submission in the first half of 2026. However, the revised protocol, submitted in June, pushes the enrollment completion date to the fourth quarter of 2025, with a potential data readout in mid-2026 and an Accelerated Approval submission in late 2026.

The delay in the FDA approval process has had an immediate impact on Dyne Therapeutics' stock price. On June 17, 2025, the stock price fell by $2.96 per share, or 21.42%, closing at $10.86 per share. Investors are advised to stay informed about the ongoing investigation and potential developments.

Pomerantz LLP, with offices in New York, Chicago, Los Angeles, London, Paris, and Tel Aviv, is known for its expertise in corporate, securities, and antitrust class litigation. The firm has a history of recovering multimillion-dollar damages awards on behalf of class members. Investors with concerns about their investments in Dyne Therapeutics are encouraged to contact Danielle Peyton at Pomerantz LLP for more information.

References:
[1] https://www.prnewswire.com/news-releases/investor-alert-pomerantz-law-firm-investigates-claims-on-behalf-of-investors-of-dyne-therapeutics-inc----dyn-302525777.html
[2] https://www.marketscreener.com/news/pomerantz-law-firm-investigates-claims-on-behalf-of-investors-of-dyne-therapeutics-inc-dyn-ce7c51dfda8af121
[3] https://www.prnewswire.com/news-releases/investor-alert-pomerantz-law-firm-investigates-claims-on-behalf-of-investors-of-dyne-therapeutics-inc----dyn-302527446.html