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726,103 Results for "dmd therapeutics inc".
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Duchenne muscular dystrophy
With Prasad Back at FDA, Capricor To Fight DMD Cardiomyopathy Rejection
Capricor Therapeutics met with the FDA last week for a type A meeting, during which CEO Linda Marbán aimed to explain to the regulator that it got it wrong. Capricor plans to resubmit the application based on deramiocel’s existing dataset.
August 20, 2025
·
7 min read
·
Heather McKenzie
Press Releases
Dyne Therapeutics Announces FDA Breakthrough Therapy Designation for DYNE-251 in Duchenne Muscular Dystrophy (DMD)
August 5, 2025
·
8 min read
Press Releases
Italfarmaco Announces Exclusive Distribution Agreement with Multicare Pharma for DMD Treatment Givinostat in Brazil
September 16, 2025
·
5 min read
Duchenne muscular dystrophy
Avidity Touts Functional Improvements for DMD Therapy, Clearing Way to FDA
Analysts at BMO Capital Markets expect the lack of other exon-44-skiping therapies to facilitate a “smooth” approval process for Avidity’s del-zota.
September 11, 2025
·
2 min read
·
Tristan Manalac
Opinion
DMD Gene Therapy’s Inflection Point and the Case for Small Molecules
As AAV9 and CRISPR programs navigate safety, delivery and scalability hurdles, small molecules offer a deployable, scalable bridge, complementing genetic approaches and accelerating meaningful impact for patients with Duchenne muscular dystrophy.
September 4, 2025
·
6 min read
·
David Craig
Gene therapy
Doctors Still Prescribing Sarepta’s DMD Gene Therapy After Safety Concerns
A new analyst survey suggests that doctors are still prescribing Sarepta’s Elevidys, even after a series of deaths in certain populations marred the gene therapy’s record.
September 16, 2025
·
3 min read
·
Annalee Armstrong
Complete response letters
Capricor Plunges on FDA Rejection of DMD Cell Therapy
In its complete response letter, the FDA cited insufficient evidence establish deramiocel’s effectiveness for cardiomyopathy associated with Duchenne muscular dystrophy. The decision comes after CBER Director Vinay Prasad canceled an advisory committee meeting for the therapy.
July 11, 2025
·
3 min read
·
Tristan Manalac
Layoffs
Sarepta Tags DMD Gene Therapy Elevidys With Black Box Warning, Axes 500 Staff
Following the death of two teenage patients with Duchenne muscular dystrophy following Elevidys treatment, Sarepta Therapeutics adds a black box warning to the gene therapy for acute liver injury and failure and parts with more than a third of employees.
July 16, 2025
·
2 min read
·
Heather McKenzie
Gene therapy
FDA Does 180 on Sarepta, Freeing DMD Gene Therapy for Ambulatory Patients
The swift FDA action removes an overhang from Sarepta and allows Elevidys to return to the market without another safety study, as had been feared, Jefferies analysts said Monday.
July 28, 2025
·
2 min read
·
Annalee Armstrong
Press Releases
Precision BioSciences Receives FDA Orphan Drug Designation for PBGENE-DMD for the Treatment of Duchenne Muscular Dystrophy
July 23, 2025
·
9 min read
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