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Antisense Therapeutics Astellas Pharma Avidity Biosciences BioMarin Pharmaceuticals Capricor Therapeutics Catalyst Pharmaceuticals Dyne Therapeutics Edgewise Therapeutics Entrada Therapeutics FDA FibroGen Italfarmaco ITF Therapeutics NS Pharma PepGen Percheron Therapeutics Pfizer Pliant Therapeutics Precision Biosciences PTC Therapeutics REGENXBIO Roche Santhera Sarepta Therapeutics Satellos Bioscience Solid Biosciences Upsher-Smith Wave Life Sciences
July 3, 2026

Sarepta Shares Community Letter and Release Sarepta Announces FDA for Acceptance of sNDAs for AMONDYS 45® and VYONDYS 53®

On June 30, 2026, Sarepta Therapeutics, Inc. announced that the U.S. Food and Drug Administration (FDA) has accepted for filing the supplemental New Drug Applications (sNDAs) for AMONDYS 45® (casimersen)...
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July 3, 2026

Satellos Receives FDA Fast Track Designation for SAT-3247 for the Treatment of Duchenne Muscular Dystrophy

On June 29, 2026, Satellos Bioscience Inc., announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to SAT-3247 for the treatment of Duchenne. Please read...
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July 3, 2026

Solid Biosciences Letter to the Duchenne Community for INSPIRE DUCHENNE and Phase 3 IMPACT DUCHENNE Clinical Studies

On June 26, 2026, Solid Biosciences, Inc. shared a Letter to the Duchenne Community containing updates on the INSPIRE DUCHENNE and Phase 3 IMPACT DUCHENNE clinical studies, regulatory engagement, and...
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July 3, 2026

REGENXBIO Completes Dosing in Confirmatory Study of RGX-202, Marking Completion of Registrational Development Program and Supporting Planned BLA Submission in Q3 2026

On June 24, 2026, REGENXBIO Inc. announced the successful completion of dosing in the confirmatory study of RGX-202, a potential best-in-class gene therapy for Duchenne muscular dystrophy. They also shared...
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June 17, 2026

Italfarmaco Announces Health Canada Acceptance and Priority Review of New Drug Submission for Givinostat as a Duchenne Muscular Dystrophy Treatment

On June 10, 2026, Italfarmaco S.p.A. announced that Health Canada has accepted for review the New Drug Submission (NDS) for givinostat (Duvyzat®) for the treatment of Duchenne muscular dystrophy (DMD)....
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June 4, 2026

Avidity Biosciences Update to the Duchenne Community on Status of DMD45 Investigational Program

On June 4, 2026, Avidity Biosciences shared an update on the planned AOC 1045 clinical trial for individuals with Duchenne muscular dystrophy amenable to exon 45 skipping (DMD45). To view...
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June 2, 2026

Entrada Shares June Duchenne Community Newsletter

On June 2, 2026, Entrada Therapeutics, Inc. shared a Community Letter for the Duchenne community outlining updates on clinical studies and more.  To view their Community Letter, please click here.
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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...
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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...
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May 14, 2026

REGENXBIO Announces Positive Topline Results from Pivotal Phase III AFFINITY DUCHENNE® Study of RGX-202

On May 14, 2026 REGENXBIO Inc. announced positive topline and interim functional data from the pivotal Phase III portion of the Phase I/II/III AFFINITY DUCHENNE® trial of RGX-202, a potential...
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