Duchenne News Tags: Sarepta Therapeutics

On November 25, 2025, Sarepta Therapeutics, Inc. announced that the U.S. Food and Drug Administration (FDA) has approved dosing in Cohort 8 of ENDEAVOR (Study 9001-103). The purpose of Cohort...

On November 16, 2025, Sarepta Therapeutics Inc. shared a Community Letter with updates regarding the label for ELEVIDYS, Sarepta’s approved gene therapy for Duchenne muscular dystrophy. To view Sarepta’s Community...

On November 3, 2025, Sarepta Therapeutics, Inc. reported financial results for the third quarter of 2025 and the completion of ESSENCE, its global, Phase 3 randomized, double-blind, placebo-controlled study evaluating...

On July 28, 2025, Sarepta Therapeutics shared news of the FDA’s announcement that Sarepta may resume ELEVIDYS shipments for ambulatory patients. This enables Sarepta to lift the voluntary pause of...

It is with profound sadness that we share the news of the passing of a member of our community following treatment with ELEVIDYS. Sarepta has reported that the individual living...

On January 27, 2025, Sarepta Therapeutics announced positive topline results from Part 2 of EMBARK (Study SRP-9001-301), a global, randomized, double-blind, placebo-controlled, Phase 3 clinical study of ELEVIDYS (delandistrogene moxeparvovec-rokl),...

A full update on Sarepta's decision to discontinue development of SRP-5051.

Breaking news: US FDA has expanded approval of Sarepta Therapeutics’ gene therapy, Elevidys to Duchenne muscular dystrophy patients ages 4 and above. Elevidys has received traditional FDA approval for ambulatory...

Sarepta announces the U.S. Food and Drug Administration (FDA) has accepted and filed the Company's efficacy supplement to the Biologics License Application for ELEVIDYS.

Sarepta shares a press release announcing positive data from Part B of the MOMENTUM study.

Sarepta shares an update on efficacy supplement for ELEVIDYS.

Sarepta shares topline results from the EMBARK study and more in a Community Letter.

Sarepta announces U.S. Food and Drug Administration accelerated approval of ELEVIDYS.