DYN
Dyne Therapeutics, Inc.·Healthcare
18.16
0.055%(+0.01)
Close PriceLast Updated: — ET
52W L: $8.0652W H: $25.00
DYN NEWS
zacks.com
22h ago
Dyne Therapeutics Stock Gains 4.5% After BLA Filing for DMD Therapy
DYN shares jump after the company files a BLA with the FDA for z-rostudirsen in Duchenne muscular dystrophy.
globenewswire.com
2d ago
Dyne Therapeutics Announces Submission of Biologics License Application (BLA) to U.S. FDA for Z-Rostudirsen in Exon 51 Duchenne Muscular Dystrophy (DMD)
- Submission for Accelerated Approval based on dystrophin as a surrogate endpoint - - In the registrational expansion cohort of the DELIVER trial, treatment with z-rostudirsen resulted in a robust and statistically significant increase in dystrophin production with functional improvement observed across multiple clinical endpoints and a favorable safety profile 1 - - Proposed dosing regimen of 20 mg/kg administered intravenously once every 4 weeks (Q4W) - WALTHAM, Mass., May 26, 2026 (GLOBE NEWSWIRE) -- Dyne Therapeutics, Inc. (Nasdaq: DYN), a clinical-stage company focused on delivering functional improvement for people living with genetically driven neuromuscular diseases, today announced the submission of a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for zeleciment rostudirsen (z-rostudirsen, also known as DYNE-251) 20 mg/kg Q4W for the treatment of individuals with Duchenne muscular dystrophy (DMD) amenable to exon 51 skipping.
seekingalpha.com
6d ago
Dyne Therapeutics: 'Strong Buy' Due To Upcoming Z-Rostudirsen BLA Submission
Dyne Therapeutics, Inc. retains a Strong Buy rating, driven by clinical progress in DM1 and DMD programs targeting significant unmet needs. DYN expects to file a BLA for z-rostudirsen in DMD exon 51 skipping patients in Q2 2026, with potential commercialization by Q1 2027. Top-line data from the phase 1/2 ACHIEVE REC study in DM1 is anticipated in Q1 2027, supporting future accelerated approval filings.
zacks.com
6d ago
Dyne Stock Gains 10% on Initiation of Late-Stage Study in DMD Patients
DYN shares jump 10% after launching a phase III study of z-rostudirsen in Duchenne muscular dystrophy patients amenable to exon 51 skipping.
globenewswire.com
May 20
Dyne Therapeutics Reports Inducement Grants Under Nasdaq Listing Rule 5635(c)(4)
WALTHAM, Mass., May 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 diseases, today announced that it has granted inducement equity awards to 17 newly hired employees.
globenewswire.com
May 20
Dyne Therapeutics Announces Initiation of Phase 3 FORZETTO Trial of Z-Rostudirsen in Duchenne Muscular Dystrophy (DMD) Ahead of Planned BLA Submission for U.S. Accelerated Approval
- 72-week trial will enroll approximately 90 participants; first site now open for enrollment - - Primary endpoint is rise from floor (RFF) velocity with multiple secondary endpoints to assess muscle and pulmonary function - - FORZETTO trial design and protocol aligned with FDA; trial intended to serve as confirmatory trial for traditional approval in the U.S. and support ex-U.S. marketing applications - WALTHAM, Mass., May 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 diseases, today announced the initiation of the Phase 3 FORZETTO trial of zeleciment rostudirsen (z-rostudirsen, also known as DYNE-251), in individuals with Duchenne muscular dystrophy (DMD) amenable to exon 51 skipping.
