#USA #New York #Securities Fraud #Pomerantz LLP #Dyne Therapeutics

Pomerantz Investigates Dyne Therapeutics Amid FDA Approval Concerns

On August 11, 2025, Pomerantz LLP announced that it is investigating potential claims from investors of Dyne Therapeutics, Inc., a company known for its work in developing therapies for genetic disorders. This investigation arises in light of serious allegations regarding the company's business practices, specifically around securities fraud and unlawful conduct.

Background on Dyne Therapeutics

Dyne Therapeutics, traded on NASDAQ under the ticker DYN, is focused on the development of innovative therapies, including a treatment for myotonic dystrophy type 1 (DM1), known as DYNE-101. Recently, the company faced a setback after it issued a press release on June 17, 2025, announcing a delay in filing for FDA approval for this promising therapy.

Initially, Dyne had been on track to complete enrollment for a critical part of its trial by mid-2025 and expected to submit for regulatory approval in the first half of 2026. However, following a key meeting with the FDA in May, the company opted to revise its protocol, which has now pushed back their timeline significantly. According to the revised schedule, Dyne aims to complete enrollment for its global ACHIEVE trial by late 2025, with hopes of a data readout in mid-2026 and a potential submission for accelerated approval by late 2026.

Impact on Investors

The news of the FDA’s approval delay had a sharp negative impact on Dyne's stock prices, plummeting by $2.96 per share or 21.42%, closing at $10.86 on the day the announcement was made. Such drastic fluctuations in stock prices have raised concerns among investors, prompting Pomerantz LLP to investigate whether Dyne and some of its executives played a role in the decline by failing to disclose critical business information.

Investors affected by this situation are encouraged to reach out to Danielle Peyton at Pomerantz for more information on possibly joining a class action. They can find assistance by contacting the firm directly at the provided email and phone number.

About Pomerantz LLP

Founded over 85 years ago, Pomerantz LLP is a prestigious law firm recognized for its expertise in corporate securities and antitrust class litigation. The firm is noted for its legacy of fighting against securities fraud and protecting the interests of investors. With offices located globally in cities such as New York, Chicago, London, and Tel Aviv, Pomerantz has successfully recovered millions of dollars for its clients in the past. Their long-standing commitment to justice in securities class-action cases continues to make them a reliable advocate for shareholders facing corporate misconduct.

For investors of Dyne Therapeutics, this investigation brings to light the complexities and risks associated with biotech investments, especially when navigating regulatory approvals. As the situation develops, keeping informed and seeking legal counsel may prove critical for individuals potentially affected by these corporate actions.

For further details or to inquire about the investigation, interested parties are encouraged to contact Pomerantz LLP directly, emphasizing the importance of being proactive in safeguarding their investment interests.