StreetInsider.com News Articles

Form 8-K Dyne Therapeutics, Inc. For: Jun 03

Wed, 03 Jun 2026 07:35:00 -0400

si-local-file:///var/storage/secattach/20260603/26595446.html

Form 8-K Dyne Therapeutics, Inc. For: Jun 03

Wed, 03 Jun 2026 07:35:00 -0400

si-local-file:///var/storage/secattach/20260603/26595446.html

Dyne Therapeutics completes enrollment in myotonic dystrophy trial

Wed, 03 Jun 2026 07:30:20 -0400

Dyne Therapeutics Inc. (NASDAQ: DYN) announced it has completed enrollment in the registrational expansion cohort of its ACHIEVE trial evaluating z-basivarsen for myotonic dystrophy type 1.

The registrational expansion cohort enrolled 71 participants. The company plans to release topline data from this cohort in the first quarter of 2027 to support a potential Biologics License Application submission for U.S. Accelerated Approval in the third quarter of 2027.

Z-basivarsen, also known as DYNE-101, is an investigational antisense oligonucleotide conjugated to an antigen-binding fragment that targets the transferrin receptor 1. The therapy is designed to reduce toxic nuclear DMPK RNA in patients with DM1.

The

Dyne Therapeutics Announces Completion of Enrollment in Registrational Expansion Cohort of ACHIEVE Trial of Z-Basivarsen for Myotonic Dystrophy Type 1 (DM1)

Wed, 03 Jun 2026 07:30:00 -0400

- Registrational expansion cohort enrolled 71 participants; topline data planned for Q1 2027 -

WALTHAM, Mass., June 03, 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 completion of enrollment in the registrational expansion cohort (REC) of the Phase 1/2 ACHIEVE trial of zeleciment basivarsen (z-basivarsen, also known as DYNE-101) in individuals with DM1.

“Completing enrollment in the registrational expansion cohort of ACHIEVE is a critical milestone as we advance a potentially best-in-class

Dyne Therapeutics Announces Completion of Enrollment in Registrational Expansion Cohort of ACHIEVE Trial of Z-Basivarsen for Myotonic Dystrophy Type 1 (DM1)

Wed, 03 Jun 2026 07:30:00 -0400

- Registrational expansion cohort enrolled 71 participants; topline data planned for Q1 2027 -

Form 4 Dyne Therapeutics, Inc. For: May 26 Filed by: Posner Brian S

Thu, 28 May 2026 16:11:00 -0400

si-local-file:///var/storage/secattach/20260528/26567380.html

Form 4 Dyne Therapeutics, Inc. For: May 26 Filed by: Posner Brian S

Thu, 28 May 2026 16:11:00 -0400

si-local-file:///var/storage/secattach/20260528/26567380.html

Dyne Therapeutics submits FDA application for DMD treatment

Tue, 26 May 2026 07:31:25 -0400

Dyne Therapeutics Inc. (NASDAQ: DYN) submitted a Biologics License Application to the U.S. Food and Drug Administration for z-rostudirsen, a treatment for Duchenne muscular dystrophy patients amenable to exon 51 skipping.

The Waltham, Massachusetts-based company filed for accelerated approval based on dystrophin as a surrogate endpoint. The proposed dosing regimen is 20 mg/kg administered intravenously once every four weeks.

The application is based on results from the registrational expansion cohort of the DELIVER trial, where treatment with z-rostudirsen resulted in increased dystrophin production with functional improvement observed across multiple clinical endpoints, according to the company's press release.

"This is a significant milestone for

Dyne Therapeutics submits FDA application for DMD treatment

Tue, 26 May 2026 07:31:25 -0400

"This is a significant milestone for

Dyne Therapeutics Announces Submission of Biologics License Application (BLA) to U.S. FDA for Z-Rostudirsen in Exon 51 Duchenne Muscular Dystrophy (DMD)

Tue, 26 May 2026 07:30:00 -0400

- 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 profile¹ -

- 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

Dyne Therapeutics Announces Submission of Biologics License Application (BLA) to U.S. FDA for Z-Rostudirsen in Exon 51 Duchenne Muscular Dystrophy (DMD)

Tue, 26 May 2026 07:30:00 -0400

- Submission for Accelerated Approval based on dystrophin as a surrogate endpoint -

- 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

Form 4 Dyne Therapeutics, Inc. For: May 20 Filed by: Posner Brian S

Fri, 22 May 2026 16:10:00 -0400

si-local-file:///var/storage/secattach/20260522/26541680.html

Form 4 Dyne Therapeutics, Inc. For: May 20 Filed by: Posner Brian S

Fri, 22 May 2026 16:10:00 -0400

si-local-file:///var/storage/secattach/20260522/26541680.html

Dyne Therapeutics Reports Inducement Grants Under Nasdaq Listing Rule 5635(c)(4)