Core Viewpoint - Dyne Therapeutics is facing an investigation regarding potential securities fraud and unlawful business practices following a delay in FDA approval for its experimental therapy DYNE-101 for myotonic dystrophy type 1 [1][3]. Group 1: Company Developments - On June 17, 2025, Dyne Therapeutics announced a delay in filing for FDA approval of DYNE-101, which is intended for treating myotonic dystrophy type 1 [3]. - The company revised its protocol for the Phase 1/2 global ACHIEVE trial after a Type C meeting with the FDA, with the new enrollment goal set for the fourth quarter of 2025 and a potential data readout in mid-2026 [3]. - The previous timeline aimed for enrollment completion in mid-2025 and regulatory submission in the first half of 2026, indicating a significant shift in the project timeline [3]. Group 2: Market Reaction - Following the announcement of the delay, Dyne's stock price dropped by $2.96 per share, or 21.42%, closing at $10.86 per share on June 17, 2025 [4].
INVESTOR ALERT: Pomerantz Law Firm Investigates Claims On Behalf of Investors of Dyne Therapeutics, Inc. - DYN