Duchenne News Tags: Dyne Therapeutics

May 28, 2026

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

On May 26, 2026, Dyne Therapeutics, Inc. 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...

May 20, 2026

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

On May 20, 2026, Dyne Therapeutics, Inc. 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...

March 9, 2026

Dyne Therapeutics Announces New Positive Cardiopulmonary Results from DELIVER Trial of Z-Rostudirsen in Duchenne Muscular Dystrophy (DMD)

On March 8, 2026, Dyne Therapeutics, Inc. (Nasdaq: DYN) announced additional positive data from the ongoing Phase 1/2 DELIVER clinical trial of zeleciment rostudirsen (z-rostudirsen, also known as DYNE-251), in...

August 4, 2025

Dyne Therapeutics Announces FDA Breakthrough Therapy Designation for DYNE-251 in Duchenne Muscular Dystrophy

On August 4, 2025, Dyne Therapeutics, Inc. announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation to DYNE-251 for the treatment of patients with Duchenne...

March 17, 2025

Dyne Therapeutics Announces New Long-Term Clinical Data from Phase 1/2 DELIVER Trial of DYNE-251 in Duchenne Muscular Dystrophy Demonstrating Unprecedented and Sustained Functional Improvement Through 18 Months

On March 17, 2025, Dyne Therapeutics Inc. announced new long-term clinical data from its ongoing Phase 1/2 DELIVER trial of DYNE-251 demonstrating unprecedented and sustained functional improvement at the selected...

January 10, 2025

Dyne Therapeutics Reports New Clinical Data Showing Compelling Impact on Multiple Measures of Myotonic Dystrophy Type 1 (DM1); Dyne Plans to Initiate Registrational Expansion Cohort to Support Potential Submission for U.S. Accelerated Approval for DYNE-101 in DM1 in H1 2026

Dyne Therapeutics announces new clinical data from its ongoing Phase 1/2 ACHIEVE trial of DYNE-101.

September 3, 2024

Dyne Therapeutics Announces New Clinical Data from Phase 1/2 DELIVER Trial of DYNE-251 in Duchenne Muscular Dystrophy Demonstrating Unprecedented Dystrophin Expression and Functional Improvement in Multiple Cohorts

Dyne Therapeutics announced new clinical data from its ongoing Phase 1/2 DELIVER trial of DYNE-251.

May 20, 2024

Dyne Therapeutics Announces New Clinical Data from ACHIEVE Trial of DYNE-101 in DM1 and DELIVER Trial of DYNE-251 in DMD Demonstrating Compelling Impact on Key Disease Biomarkers and Improvement in Multiple Functional Endpoints

On Monday, May 20, Dyne Therapeutics announced positive clinical data from its ongoing Phase 1/2 ACHIEVE trial of DYNE-101 in patients with myotonic dystrophy type 1 and its ongoing Phase...

January 3, 2024

Dyne Therapeutics Announces Positive Initial Clinical Data from ACHIEVE Trial in DM1 Patients and DELIVER Trial in DMD Patients Demonstrating Promise of the FORCE™ Platform in Developing Therapeutics for Rare Muscle Diseases

Dyne announces positive initial clinical data from its ACHIEVE trial of DYNE-101.

October 30, 2023

Dyne Therapeutics Reports Third Quarter 2023 Financial Results and Provides Update on Significant Progress for ACHIEVE and DELIVER Trials and Upcoming Clinical Milestones

Dyne Therapeutics reports financial results for the third quarter of 2023 and more.

March 23, 2023

Dyne Therapeutics Receives FDA Orphan Drug and Rare Pediatric Designations for DYNE-251 for the Treatment of Duchenne

November 7, 2022

Dyne Therapeutics Receives FDA Fast Track Designation for DYNE-251 for the Treatment of Duchenne Muscular Dystrophy

Dyne Therapeutics receives FDA Fast Track designation for DYNE-251 for treatment of Duchenne

August 11, 2022

Dyne Therapeutics Announces “Breakthrough Article” Publication of Duchenne Muscular Dystrophy Program Data in Nucleic Acids Research

On August 10, 2022, Dyne Therapeutics announced the publication of Duchenne muscular dystrophy preclinical data: Enhanced Exon Skipping and Prolonged Dystrophin Restoration Achieved by TfR1-Targeted Delivery of Antisense Oligonucleotide Using...

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