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

Pomerantz Law Firm's Investigation into Dyne Therapeutics

In a recent development, Pomerantz LLP, a renowned law firm specializing in securities class actions, has announced an active investigation into potential claims arising from the conduct of Dyne Therapeutics, Inc., a company listed on NASDAQ under the ticker symbol DYN. The inquiry aims to determine if Dyne has engaged in securities fraud or other illegal business practices that could negatively impact its investors.

Recent Developments at Dyne Therapeutics

On June 17, 2025, Dyne Therapeutics disclosed a significant delay concerning its application for FDA approval of DYNE-101, an experimental treatment designed for myotonic dystrophy type 1 (DM1). This announcement followed a Type C meeting with FDA representatives held in May, where Dyne agreed to revise the protocol for its Phase 1/2 ACHIEVE trial for the drug. The revised protocol was submitted to the FDA in June and aimed to incorporate changes beneficial for the ongoing Registrational Expansion Cohort of the study.

Initially, Dyne had set an ambitious timeline, hoping to complete the cohort enrollments by mid-2025 and to submit their regulatory filing in the first half of 2026. However, the updated schedule now anticipates that enrollment will conclude in the fourth quarter of 2025, with data results expected in mid-2026 and a potential Accelerated Approval submission by late 2026.

Impact on Stock Prices

Investors reacted sharply to this news, resulting in a notable decline in Dyne's stock price. Following the announcement, shares dropped by 21.42%, a loss of $2.96, bringing the closing price down to $10.86 per share on the day of the announcement. This significant price fluctuation underscores investor concerns regarding the future of Dyne's clinical trials and the implications for its market performance.

Pomerantz Law Firm’s Commitment

For investors affected by these developments, Pomerantz LLP is welcoming inquiries, encouraging anyone who believes they may have claims related to their investments in Dyne Therapeutics to reach out to Danielle Peyton for more information about potential class action lawsuits. With over 85 years of experience, Pomerantz has built a reputation for advocating on behalf of victims of securities fraud and corporate misconduct, securing considerable recoveries on behalf of class members.

Conclusion

As this situation unfolds, investors remain attentive to developments from Dyne Therapeutics, particularly concerning the progress of DYNE-101 and its regulatory pathways. The investigation spearheaded by Pomerantz Law Firm illustrates the persistent scrutiny surrounding companies in the biotechnology sector, particularly those navigating the complexities of FDA approvals during crucial trial phases.

For further information about joining class action lawsuits or inquiries regarding investments, investors are encouraged to contact Pomerantz LLP directly. As the situation progresses, Dyne Therapeutics and its stakeholders will be closely watched by the market and legal observers alike.