#United States #New York #FDA Approval #Pomerantz LLP #Dyne Therapeutics

Pomerantz Law Firm Investigates Dyne Therapeutics Amid Investor Concerns

Pomerantz LLP, a law firm known for representing investors, has initiated an investigation concerning claims on behalf of investors of Dyne Therapeutics, Inc. (NASDAQ: DYN). Recent events have raised several alarms about the company’s conduct, specifically addressing possible securities fraud or other illicit business practices related to their operations.

On June 17, 2025, Dyne Therapeutics made a significant announcement regarding a delay in its timeline for obtaining approval from the U.S. Food and Drug Administration (FDA) for its experimental therapy known as DYNE-101, aimed at treating myotonic dystrophy type 1 (DM1). The company revealed that, following a Type C meeting with the FDA’s Center for Drug Evaluation and Research held in May, it was required to adjust its protocols for the Phase 1/2 global ACHIEVE trial involving DYNE-101. This revision was submitted to the FDA in June, causing previous timelines to shift dramatically.

The original plan, which aimed for completion of enrollments in mid-2025, has now been extended to the fourth quarter of 2025. The modification means that the company is now targeting a data readout in mid-2026, with hopes of submitting for potential Accelerated Approval by late 2026.

Such shifts in plans have considerable implications for investors. Following the announcement, Dyne’s stock experienced a dramatic decline, plummeting by $2.96 per share or 21.42%, closing at $10.86 on the same day. This stark drop has triggered scrutiny, prompting the Pomerantz Law Firm to look deeper into these developments and whether they might constitute violations of securities laws.

Pomerantz LLP, which boasts a legacy of over 85 years in corporate, securities, and antitrust class litigation, is determined to investigate the nuances of Dyne's communications and overall conduct. Founded by Abraham L. Pomerantz, the firm has historically taken on major cases of securities fraud and has been successful in recovering substantial damages for class members.

As this investigation unfolds, Pomerantz is encouraging affected investors to reach out for further information on participating in class actions that may emerge as a result of these inquiries. Investors who believe they have suffered due to the company’s actions are advised to contact Danielle Peyton at Pomerantz LLP for assistance.

This ongoing investigation serves as a crucial reminder of the responsibilities that companies have to their investors, particularly during critical phases of drug approval processes where delays can significantly alter investor expectations and stock performance.

Dyne Therapeutics is now under the microscope, examining how its management team addresses regulatory challenges and the timing of communications to its shareholders. As a pioneer in the field of securities class actions, Pomerantz remains committed to advocating for investor rights and ensuring transparency in the corporate sector.

Conclusion

As further developments occur, stakeholders will be watching closely how Dyne Therapeutics navigates these challenges, and how the law firm’s investigation will unfold in addressing potential injustices faced by its investors. Those interested in the latest updates should monitor both Pomerantz LLP's website and Dyne Therapeutics' press releases for new information related to this crucial matter.