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582,571 Results for "dmd therapeutics inc".
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Press Releases
Dyne Therapeutics Announces U.S. FDA Acceptance of Biologics License Application (BLA) for Z-Rostudirsen in Exon 51 Duchenne Muscular Dystrophy (DMD)
July 20, 2026
·
7 min read
Duchenne muscular dystrophy
Capricor thrown for another loop as FDA sets adcomm for DMD cardiomyopathy therapy
The FDA plans to hold an advisory committee meeting to discuss Capricor Therapeutics’ application for deramiocel, which the agency rejected last July. The news surprised CEO Linda Marbán, who told
BioSpace
the FDA has not communicated any issues of concern with the company’s resubmitted application.
June 26, 2026
·
4 min read
·
Heather McKenzie
FDA
UPDATE: FDA disputes Capricor’s claims of Phase 3 success for DMD cell therapy
In briefing documents published Monday ahead of an advisory committee meeting for deramiocel, the FDA disagreed with Capricor’s assertion that a Phase 3 trial met its primary outcome measures.
July 27, 2026
·
3 min read
·
Heather McKenzie
FDA
FDA advisers vote against approval of Capricor’s DMD therapy in chaotic adcomm meeting
During a perplexing advisory committee meeting in which FDA reviewers focused largely on the Phase 3 HOPE-3 trial’s secondary endpoint of cardiac function, experts pointed to “very fragile” data. The committee voted 9-3 against approval of deramiocel.
July 29, 2026
·
8 min read
·
Heather McKenzie
Press Releases
SK pharmteco and Genethon Showcase French Manufacturing Strength Behind Pivotal DMD Gene Therapy Program
July 21, 2026
·
6 min read
Press Releases
Dyne Therapeutics Announces Submission of Biologics License Application (BLA) to U.S. FDA for Z-Rostudirsen in Exon 51 Duchenne Muscular Dystrophy (DMD)
May 26, 2026
·
7 min read
Press Releases
Dyne Therapeutics Announces New Positive Cardiopulmonary Results from DELIVER Trial of Z-Rostudirsen in Duchenne Muscular Dystrophy (DMD)
March 9, 2026
·
9 min read
Press Releases
GEMMABio Unveils Duchenne Muscular Dystrophy (DMD) Program and Presents Preclinical Data for Next‑Generation Gene Therapies for DMD and Spinal Muscular Atrophy Type 1 (SMA1) at the ASGCT 2026 Annual Meeting
May 14, 2026
·
8 min read
Press Releases
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
May 20, 2026
·
10 min read
Duchenne muscular dystrophy
Following Sarepta Woes, Others Look To Unlock the Next Chapter in DMD Treatment
With a clutch of key data and planned regulatory applications this year from Avidity Biosciences, REGENXBIO and Capricor Therapeutics, CureDuchenne CSO Michael Kelly sees “momentum” in the Duchenne muscular dystrophy pipeline, as Sarepta’s Elevidys leaves the door open.
February 9, 2026
·
11 min read
·
Heather McKenzie
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