Pomerantz LLP Investigates Dyne Therapeutics, Inc. for Securities Fraud Claims

Strategic Insights -

Investors in Dyne Therapeutics, Inc. have been advised to contact Pomerantz LLP regarding potential securities fraud claims. On June 17, 2025, Dyne Therapeutics issued a press release indicating a delay in the filing for U.S. Food and Drug Administration ("FDA") approval of DYNE-101, an experimental therapy for myotonic dystrophy type 1. This news led to a significant decline in Dyne's stock price, falling $2.96 per share, or 21.42%, to close at $10.86 per share on the same day.

Key Takeaways:

  • Pomerantz LLP is investigating claims on behalf of investors of Dyne Therapeutics, Inc. regarding potential securities fraud.
  • Dyne Therapeutics issued a press release on June 17, 2025, indicating a delay in the filing for FDA approval of DYNE-101.
  • The delay was due to the need to revise the protocol for the Phase 1/2 global ACHIEVE trial for DYNE-101 in myotonic dystrophy type 1.
  • The revised protocol was submitted to the FDA in June, incorporating changes to the ACHIEVE trial's Registrational Expansion Cohort.
  • Under the revised schedule, Dyne intends to complete enrollment in the cohort in the fourth quarter of 2025, seeking a data readout in mid-2026 and a potential Accelerated Approval submission in late 2026.
  • The delay in FDA approval led to a stock price decline of $2.96 per share, or 21.42%, to close at $10.86 per share on June 17, 2025.
  • Pomerantz LLP is a premier firm in corporate, securities, and antitrust class litigation, with over 85 years of experience protecting the rights of victims of securities fraud and corporate misconduct.
  • The law firm has recovered numerous multimillion-dollar damages awards on behalf of class members.

Statistics:

  • Dyne Therapeutics' stock price declined by $2.96 per share, or 21.42%, on June 17, 2025.
  • The stock price closed at $10.86 per share on the same day.
  • The revised protocol for the ACHIEVE trial will be completed in the fourth quarter of 2025.
  • Dyne intends to complete enrollments in the cohort in mid-2025 and submit the regulatory submission in the first half of 2026.

Sources:

  • Pomerantz LLP, Investigation: Dyne Therapeutics, Inc. (NASDAQ: DYN)
  • PRNewswire, Pomerantz LLP Announces Investigation into Dyne Therapeutics, Inc. (NASDAQ: DYN)
  • Dyne Therapeutics, Inc., Press Release: Delay in FDA Approval of DYNE-101 for Myotonic Dystrophy Type 1