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721,092 Results for "dmd therapeutics inc".
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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
Press Releases
Precision BioSciences Receives FDA Rare Pediatric Disease Designation for PBGENE-DMD for the Treatment of Duchenne Muscular Dystrophy
June 25, 2025
·
9 min read
Duchenne muscular dystrophy
UPDATE: Second Patient Dies After Receiving Sarepta’s DMD Gene Therapy Elevidys
Sarepta’s shares crashed 41% in premarket trading Monday morning to $21.01 after the biotech reported a second death from acute liver failure, a known side effect of adeno-associated virus-based gene therapies.
June 16, 2025
·
3 min read
·
Tristan Manalac
Duchenne muscular dystrophy
Regenxbio Fails To Best Sarepta’s Elevidys With New Data for DMD Gene Therapy
Interim results from a small group of children in a Phase I/II trial are essentially in line with that of Elevidys, according to BMO Capital Markets analysts.
June 5, 2025
·
2 min read
·
Dan Samorodnitsky
Duchenne muscular dystrophy
5 DMD Candidates to Watch in 2025
Riding recent momentum in the Duchenne muscular dystrophy space, Capricor Therapeutics, Wave Life Sciences, Regenxbio and more aim to deliver the next wave of progress with near-term data and regulatory milestones.
January 27, 2025
·
6 min read
·
Kate Goodwin
Press Releases
Precision BioSciences Presents Preclinical Efficacy and Durability Data on PBGENE-DMD for the Treatment of Duchenne Muscular Dystrophy (DMD) at the 2025 Muscular Dystrophy Association (MDA) Clinical & Scientific Conference
March 19, 2025
·
11 min read
Press Releases
Precision BioSciences Accelerates Development of PBGENE-DMD Within its Wholly Owned Organic Pipeline and Highlights Pre-clinical Evidence at the American Society of Gene and Cell Therapy (ASGCT) Annual Meeting
May 14, 2025
·
13 min read
Press Releases
Wave Life Sciences Announces Positive Data from FORWARD-53 Clinical Trial in DMD Including Significant Functional Benefit and Reversal of Muscle Damage after 48 Weeks of Dosing with WVE-N531
March 27, 2025
·
14 min read
Press Releases
PepGen Announces Update to Phase 2 CONNECT2-EDO51 Study in Patients with DMD
March 5, 2025
·
7 min read
Gene Therapy
Sarepta Shares Crash 22% After Patient on DMD Gene Therapy Elevidys Dies
After a patient taking the Duchenne muscular dystrophy gene therapy Elevydis died of liver injury, Sarepta will update the label to reflect the safety signal.
March 18, 2025
·
2 min read
·
Tristan Manalac
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