DYNE-251

FDA Accepts Dyne Therapeutics’ Biologics License Application for Z-Rostudirsen

Today, Dyne Therapeutics announced that the U.S. Food and Drug Administration (FDA) has accepted the company’s Biologics License Application (BLA) for zeleciment rostudirsen (z-rostudirsen) for the treatment of individuals living with Duchenne muscular dystrophy who…

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Dyne Submits BLA to FDA for z-rostudirsen (DYNE-251) in Duchenne Amenable to Exon 51 Skipping

Today, Dyne Therapeutics announced that the company has submitted a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for zeleciment rostudirsen (z-rostudirsen, DYNE-251) for individuals living with Duchenne who are amenable…

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Dyne Announces Phase 3 Trial of Z-Rostudirsen, Plans for Submitting Biologics License Application to FDA

Dyne Therapeutics today announced the initiation of the company’s Phase 3 FORZETTO trial of zeleciment rostudirsen (z-rostudirsen, DYNE-251), in individuals living with Duchenne who are amenable to exon 51 skipping. Z-rostudiresen is an investigational exon…

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December 8, 2025

Dyne Therapeutics Announces Positive Topline Results from Phase 1/2 DELIVER Trial of Z-Rostudirsen in Duchenne

Dyne Therapeutics has announced positive topline results from its Registrational Expansion Cohort (REC) of the Phase 1/2 DELIVER trial of zeleciment rostudirsen (z-rostudirsen, also known as DYNE-251) in people living with Duchenne who are amenable…

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Watch: Dyne Therapeutics — The Clinical Impact of the FORCE™ Platform for Duchenne (Webinar Recording)

Dyne Therapeutics recently joined PPMD for a community webinar on the DELIVER clinical trial evaluating DYNE-251. The Dyne team provided the latest updates on the Phase 1/2 global DELIVER study of the company’s investigational therapy…

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September 3, 2024

Dyne Therapeutics Announces Positive New Clinical Data from Phase 1/2 DELIVER Trial of DYNE-251 in Duchenne

Dyne Therapeutics, Inc. has announced positive new clinical data from its ongoing Phase 1/2 DELIVER trial of DYNE-251 in patients with Duchenne who are amenable to exon 51 skipping. DYNE-251 is an exon skipping product…

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August 20, 2024

WATCH: Advancing DYNE-251 – An Investigational Medicine for Duchenne to Deliver for Patients (Webinar Recording)

Dyne Therapeutics recently joined PPMD for a presentation of clinical data from the DELIVER Trial of DYNE-251 in individuals living with Duchenne muscular dystrophy who are amenable to exon 51 skipping, first released on May…

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Dyne Therapeutics Shares New Clinical Data from DELIVER Trial of DYNE-251 in Duchenne Patients

Dyne Therapeutics has shared new clinical data from the ongoing DELIVER trial of DYNE-251 in patients with Duchenne who are amenable to exon 51 skipping. DYNE-251 is an exon skipping product that combines a PMO…

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February 8, 2024

Watch: Dyne Therapeutics — Advancing DYNE-251, an Investigational Medicine for DMD (Webinar Recording)

Dyne Therapeutics recently joined PPMD for a community webinar to present initial clinical data from the DELIVER trial of DYNE-251, a next-generation exon skipping investigational product, in individuals with Duchenne who are amenable to exon…

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January 3, 2024

Dyne Therapeutics Announces Positive Initial Clinical Data from DELIVER Trial in Duchenne Patients

Dyne Therapeutics today announced positive initial clinical data from its DELIVER trial of DYNE-251 in patients with Duchenne who are amenable to exon 51 skipping. Dyne-251 is an exon skipping product that combines a PMO…

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