Core Viewpoint - Dyne Therapeutics is facing an investigation regarding potential securities fraud or unlawful business practices following a delay in FDA approval for its experimental therapy DYNE-101 for myotonic dystrophy type 1 [1][2]. Group 1: Company Developments - On June 17, 2025, Dyne Therapeutics announced a delay in filing for FDA approval of DYNE-101, which is an experimental therapy for myotonic dystrophy type 1 [2]. - The company revised its protocol for the Phase 1/2 global ACHIEVE trial for DYNE-101 after a Type C meeting with the FDA, with the revised protocol submitted in June [2]. - Dyne now plans to complete enrollment in the Registrational Expansion Cohort by the fourth quarter of 2025, aiming for a data readout in mid-2026 and a potential Accelerated Approval submission in late 2026 [2]. Group 2: Market Reaction - Following the announcement of the delay, Dyne's stock price fell by $2.96 per share, representing a decline of 21.42%, closing at $10.86 per share on June 17, 2025 [3].
INVESTOR ALERT: Pomerantz Law Firm Investigates Claims On Behalf of Investors of Dyne Therapeutics, Inc. - DYN