Capricor Therapeutics is seeking regulatory approval from the FDA for therapeutics targeting Duchenne Muscular Dystrophy.
3 reports, 1 independent
Updated Aug 12
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New informationRepeats or wire copies
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What happened
Capricor Therapeutics is seeking regulatory approval from the FDA for therapeutics targeting Duchenne Muscular Dystrophy.
Who's involved
What this event is mainly aboutHow it developed
Newest first. Tap a step to see who reported it.- The FDA is reviewing the Biologics License Application (BLA) submission from Capricor Therapeutics regarding its therapeutics for Duchenne Muscular Dystrophy (DMD).Sub-event
- The FDA informed Capricor Therapeutics that regulatory review is not required for its drug.Sub-event
- The FDA announced its decision regarding the Advisory Committee for Capricor Therapeutics' drug, deramiocel, on June 26, 2025.Sub-event
- Capricor Therapeutics is developing therapeutics for Duchenne muscular dystrophy and had a Type A meeting scheduled with the FDA.Sub-event
Capricor Therapeutics filed for regulatory approval for its Duchenne Muscular Dystrophy therapy.1 source
- FDA indicated Advisory Committee meeting is not required for Capricor Therapeutics' drug application.
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The entities involved
- FDA
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Capricor Therapeutics (United States)
company in Beverly Hills, United States
Nothing else this week.
Related events
- Capricor Therapeutics is seeking regulatory approval from the FDA for clinical trials and has listed on the Nasdaq stock exchange, with a law firm based in New York City involved.
- A study protocol involving a company based in Mont-Saint-Guibert was approved by the U.S. FDA.
- Clinical research studies for new indications were reported by the FDA concerning a company identified as Cpt.
- A company is conducting clinical trials and seeking drug approval for the U.S. market under the FDA.
- Experimental therapies require approval from the FDA.
Coverage
Newest first; wire copies grouped- GlobeNewswireCapricor Therapeutics Reports Second Quarter 2025 Financial Results and Provides Corporate Update Type A meeting with U.S. FDA scheduled to discuss Deramiocel BLA and path toward potential approval C
- GlobeNewswireCapricor Therapeutics and Parent Project Muscular Dystrophy to Host Webinar to Review Latest Developments in the Deramiocel Program for the Treatment of Duchenne Muscular Dystrophy – Webinar to be he
- Unknown outlet