Pomerantz Law Firm Investigates Securities Claims Against Dyne Therapeutics Following FDA Approval Delay

Investor Alert: Pomerantz Law Firm Investigates Dyne Therapeutics

Pomerantz LLP, a well-respected name in securities litigation, has initiated an investigation concerning Dyne Therapeutics, Inc. (NASDAQ: DYN), focusing on potential securities fraud claims involving investors in the company. This comes in the wake of a troubling development announced on June 17, 2025, regarding delays in obtaining FDA approval for DYNE-101, an experimental treatment aimed at myotonic dystrophy type 1 (DM1).

In the press release issued by Dyne, it was revealed that the company would not meet its previously set timeline for filing with the U.S. Food and Drug Administration (FDA). Following a key Type C meeting with the FDA’s Center for Drug Evaluation and Research in May, Dyne revised their protocol for Phase 1/2 of the global ACHIEVE trial for DYNE-101. This new protocol was officially submitted to the FDA in June but included notable changes to the Registrational Expansion Cohort of their study.

The initial goal was to complete patient enrollments for this cohort by mid-2025, aiming to generate data for a regulatory submission in the first half of 2026. However, with the adjusted schedule now in place, Dyne plans to complete cohort enrollments by the end of 2025, with hopes for a data readout by mid-2026, followed by a possible Accelerated Approval request in late 2026. The announcement led to a significant drop in Dyne's stock price, which fell by $2.96 per share, reflecting a 21.42% decline to close at $10.86.

Given these developments, investors are urged to examine the implications of these delays and the company's past operational disclosures. Pomerantz LLP, with its extensive experience in corporate litigation, seeks to help investors navigate potential legal avenues stemming from this situation.

Pomerantz LLP was founded by the late Abraham L. Pomerantz, recognized as a pioneer in class action litigation, particularly in the realm of securities fraud. The firm has a long-standing reputation for fighting on behalf of those impacted by corporate misconduct, and it remains committed to securing justice for its clients. With its offices spanning across major cities including New York, London, and Tel Aviv, Pomerantz LLP continues to play a crucial role in holding companies accountable for their actions.

Investors who believe they might be affected by this situation can reach out to Danielle Peyton at Pomerantz LLP for further information regarding their legal rights and potential actions. As the investigation unfolds, it serves as a reminder of the need for transparency and accountability in the corporate sector, especially concerning the health of investors' interests.

For those interested in becoming part of the potential class action against Dyne Therapeutics, contacting the firm promptly is advisable to ensure that their concerns are adequately represented.

Pomerantz's legacy in class action lawsuits has yielded numerous multi-million dollar verdicts in favor of investors, indicating the firm's dedicated endeavor to restore losses incurred due to corporate noncompliance or misconduct. As stakeholders await further updates about the FDA's decision regarding DYNE-101, legal avenues remain open for those impacted by Dyne's operational adjustments.