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281,682 Results for "capricor therapeutics".
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Duchenne muscular dystrophy
Capricor Heads Back to FDA With Pivotal Results for DMD Cardiomyopathy Therapy
Six months after receiving a surprise rejection due to what the FDA called “lack of substantial evidence of effectiveness,” Capricor’s cell therapy deramiocel showed significant benefits in upper-limb function and slowed decline in cardiac function in a Phase III trial.
December 3, 2025
·
3 min read
·
Heather McKenzie
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
Capricor Therapeutics Announces Pricing of $150 Million Public Offering of Common Stock
December 5, 2025
·
5 min read
Press Releases
Capricor Therapeutics Presents New Data Demonstrating a Scalable Framework for Loading Therapeutic Oligonucleotides into Exosomes at AAEV 2025
November 24, 2025
·
5 min read
FDA
‘Unprecedented’ FDA Leaks Sow Confusion for Patients, Sarepta and Capricor
Sarepta and Capricor learned of key regulatory decisions from the media and investors, and Duchenne muscular dystrophy families have turned to the news for answers. Meanwhile, the FDA insists it remains committed to notifying companies of any regulatory action before sharing information with the media or public.
August 4, 2025
·
7 min read
·
Heather McKenzie
Press Releases
Capricor Therapeutics Reports Third Quarter 2025 Financial Results and Provides Corporate Update
November 10, 2025
·
13 min read
Press Releases
Capricor Therapeutics and Parent Project Muscular Dystrophy to Host Webinar Highlighting Positive Phase 3 HOPE-3 Topline Results in Duchenne Muscular Dystrophy
December 17, 2025
·
4 min read
Press Releases
Capricor Therapeutics to Present Third Quarter 2025 Financial Results and Recent Corporate Update on November 10
November 3, 2025
·
4 min read
Press Releases
Capricor Therapeutics Announces Positive Topline Results from Pivotal Phase 3 HOPE-3 Study of Deramiocel in Duchenne Muscular Dystrophy
December 3, 2025
·
10 min read
FDA
FDA Reversals Send UniQure, Biohaven, Capricor, More Into a ‘Tailspin’
Since July, several biotechs have been forced to pivot as previous agreements with the FDA around evidence required for approval were reversed, a phenomenon that, according to experts, could portend a more restrictive regulator.
November 24, 2025
·
7 min read
·
Heather McKenzie
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