Pomerantz Law Firm Investigates Securities Claims from Dyne Therapeutics Investors Amid FDA Delays

Pomerantz LLP, a prestigious law firm known for its expertise in securities and antitrust litigation, is currently investigating claims made by investors of Dyne Therapeutics, Inc. (NASDAQ: DYN). This inquiry stems from significant concerns regarding potential securities fraud and other illegal business practices by the company and its top executives.

The focus of the investigation was prompted by a June 17, 2025 press release from Dyne Therapeutics, which disclosed delays in obtaining United States Food and Drug Administration (FDA) approval for DYNE-101, an experimental treatment aimed at myotonic dystrophy type 1 (DM1). This announcement came after the firm engaged in a Type C meeting with the FDA’s Center for Drug Evaluation and Research in May, where they arrived at a revised protocol for the Phase 1/2 global ACHIEVE trial concerning DYNE-101.

Initially, Dyne Therapeutics aimed to complete the enrollment of patients in the trial's Registrational Expansion Cohort by mid-2025, with plans to submit regulatory documentation in the first half of 2026. However, the recent modification to their schedule now indicates that patient enrollment will extend into the fourth quarter of 2025, with data readout not expected until mid-2026 and a possible Accelerated Approval submission postponed to late 2026.

Following the announcement, Dyne's stock price experienced a sharp decline, dropping by $2.96—or 21.42%—closing the trading day at $10.86 per share. This market reaction underscores the heightened scrutiny on Dyne Therapeutics and the implications of these delays on investor confidence.

Pomerantz LLP’s investigations into these circumstances serve to protect the interests of investors who may have suffered losses tied to Dyne’s operational setbacks. The firm encourages affected investors to reach out to Danielle Peyton at Pomerantz to discuss their potential participation in the ongoing inquiry and to assess their rights regarding the situation.

Operating over 85 years, Pomerantz LLP has a reputation for successfully advocating for victims of securities fraud and corporate misconduct. Their storied history includes recovering multimillion-dollar settlements on behalf of investors, a testament to their commitment to shareholder rights.

In the unfolding landscape of biotech investments, transparency, and accountability remain paramount. Dyne Therapeutics’ stakeholders are reminded to stay informed and engage with experienced legal counsel should they feel misled or disadvantaged by the company's disclosures. With Pomerantz at the helm of this investigation, investors can expect a thorough examination of the claims and, hopefully, a path toward potential recovery of their losses.