Duchenne News Tags: Sarepta Therapeutics

February 16, 2024

Sarepta Therapeutics Announces U.S. FDA Acceptance of an Efficacy Supplement to Expand the ELEVIDYS Indication

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.

January 29, 2024

Sarepta Therapeutics Announces Positive Data from Part B of MOMENTUM, a Phase 2 Study of SRP-5051 in Patients with Duchenne Muscular Dystrophy Amenable to Skipping Exon 51

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

December 22, 2023

Sarepta Therapeutics Submits Efficacy Supplement to Expand the ELEVIDYS Label to include Duchenne Muscular Dystrophy Patients without Restriction to Age or Ambulatory Status

Sarepta shares an update on efficacy supplement for ELEVIDYS.

October 31, 2023

Sarepta Therapeutics Community Letter: EMBARK Part 1 Topline Results

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

June 22, 2023

Sarepta Therapeutics Announces FDA Approval of ELEVIDYS, the First Gene Therapy to Treat Duchenne Muscular Dystrophy

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

June 8, 2023

Sarepta Provides Update for SRP-9001-303: ENVISION study enrollment in U.S.

Sarepta shares enrollment updates for SRP-9001-303 study.

May 24, 2023

Sarepta Therapeutics Announces Update on Regulatory Review of SRP-9001

Sarepta shares an update on the regulatory review of SRP-9001, a treatment of ambulant individuals with Duchenne muscular dystrophy who have a confirmed mutation of the DMD gene.

April 11, 2023

Sarepta Therapeutics Announces May 12, 2023 as Date of Advisory Committee Meeting for SRP-9001

March 17, 2023

Sarepta Therapeutics Announces Advisory Committee Meeting Will Be Held for SRP-9001

Sarepta announces advisory meeting for SRP-9001, an investigational gene therapy for the treatment of Duchenne muscular dystrophy.

February 28, 2023

Sarepta Therapeutics Announces Call for Applications for the 6th Annual Route 79, The Duchenne Scholarship Program

Sarepta announces official release of 2023-2024 Route 79 Duchenne Scholarship Program

November 28, 2022

Sarepta Announces U.S. FDA Accepts Filing and Granted Priority Review for the Biologics License Application for SRP-9001

Sarepta announces FDA filing and priority review for biologics license application for SRP-9001

September 29, 2022

Sarepta Therapeutics Submits Biologics License Application for SRP-9001 for the Treatment of Ambulant Patients with Duchenne Muscular Dystrophy

Sarepta Therapeutics Submits Biologics License Application for SRP-9001 for the Treatment of Ambulant Patients with Duchenne Muscular Dystrophy.

September 13, 2022

Sarepta Shares EMBARK (SRP-9001-301) Study Enrollment Update

On September 13, 2022, Sarepta Therapeutics shared an update announcing that their EMBARK (SRP-9001-301) study is fully enrolled.

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