- Biologics License Application (BLA) for z-rostudirsen in exon 51 Duchenne muscular dystrophy (DMD) under priority review by FDA; PDUFA target action date of January 21, 2027 - - Additional one-year clinical data from
WALTHAM, Mass., Oct. 22, 2026 (GLOBE NEWSWIRE) -- Dyne Therapeutics, Inc. (NASDAQ:DYN), a clinical-stage company focused on delivering functional improvement for people living with genetically driven neuromuscular
- Data from a pooled dose group of participants initially enrolled in the multiple ascending dose (MAD) portion of ACHIEVE showed functional improvement versus baseline, versus placebo and versus a matched natural
WALTHAM, Mass., Sept. 17, 2026 (GLOBE NEWSWIRE) -- Dyne Therapeutics, Inc. (NASDAQ:DYN), a clinical-stage company focused on delivering functional improvement for people living with genetically driven neuromuscular
- Data from a pooled dose group of participants initially enrolled in the multiple ascending dose portion of the trial to be compared against a matched natural history cohort - - Dyne also intends to provide the mean
- Data support the ongoing development of four investigational therapies for DMD amenable to skipping of exons 53, 45, 44 or 55, all of which are advancing into IND-enabling studies - - All development candidates
WALTHAM, Mass., Sept. 02, 2026 (GLOBE NEWSWIRE) -- Dyne Therapeutics, Inc. (NASDAQ:DYN), a clinical-stage company focused on delivering functional improvement for people living with genetically driven neuromuscular
WALTHAM, Mass., Aug. 20, 2026 (GLOBE NEWSWIRE) -- Dyne Therapeutics, Inc. (NASDAQ:DYN), a clinical-stage company focused on delivering functional improvement for people living with genetically driven neuromuscular
- Biologics License Application (BLA) for z-rostudirsen in exon 51 DMD accepted for review by FDA; Priority Review granted; PDUFA target action date set for January 21, 2027 - - Completed enrollment of 71 participants
- Company’s third program to enter clinical development leveraging FORCE platform with the goal of delivering functional improvement in rare neuromuscular disease - WALTHAM, Mass., July 28, 2026 (GLOBE NEWSWIRE) --
WALTHAM, Mass., July 24, 2026 (GLOBE NEWSWIRE) -- Dyne Therapeutics, Inc. (NASDAQ:DYN), a clinical-stage company focused on delivering functional improvement for people living with genetically driven neuromuscular
WALTHAM, Mass., July 23, 2026 (GLOBE NEWSWIRE) -- Dyne Therapeutics, Inc. (NASDAQ:DYN), a clinical-stage company focused on delivering functional improvement for people living with genetically driven neuromuscular
WALTHAM, Mass., July 21, 2026 (GLOBE NEWSWIRE) -- Dyne Therapeutics, Inc. (NASDAQ:DYN), a clinical-stage company focused on delivering functional improvement for people living with genetically driven neuromuscular
WALTHAM, Mass., July 21, 2026 (GLOBE NEWSWIRE) -- Dyne Therapeutics, Inc. (NASDAQ:DYN), a clinical-stage company focused on delivering functional improvement for people living with genetically driven neuromuscular
- Priority Review granted; PDUFA target action date set for January 21, 2027 - - Submission for Accelerated Approval based on dystrophin as a surrogate endpoint - - In the registrational expansion cohort of the
