Dyne Therapeutics

DYN

Market cap $2.85B

DYN shares jump after the company files a BLA with the FDA for z-rostudirsen in Duchenne muscular dystrophy.

- 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.

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.

DYN shares jump 10% after launching a phase III study of z-rostudirsen in Duchenne muscular dystrophy patients amenable to exon 51 skipping.

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.

- 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.

WALTHAM, Mass., May 13, 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 management is scheduled to participate in the following upcoming investor conferences:

Dyne Therapeutics (DYN) might move higher on growing optimism about its earnings prospects, which is reflected by its upgrade to a Zacks Rank #2 (Buy).

- Positive pre-BLA meeting completed with FDA for z-rostudirsen in exon 51 DMD; on track for BLA submission in Q2 2026 and potential launch in Q1 2027 -

- Data underscore the differentiated capability of the clinically validated FORCE platform to cross the blood-brain barrier -