Capricor Therapeutics Announces Intent to File Biologics License Application for Full Approval of Deramiocel for the Treatment of Duchenne Muscular Dystrophy Cardiomyopathy
Capricor Therapeutics, Inc. (CAPR)
Last capricor therapeutics, inc. earnings: 3/18 04:01 pm
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Source: GlobeNewswire
-BLA to be Supported by Existing and Natural History Cardiac Data as Discussed with the FDA- -Initial Label Would Include All Patients with Cardiomyopathy Associated with Duchenne Muscular Dystrophy- -Rolling Submission Planned to Commence in October 2024- -Internal GMP Manufacturing Established to Support BLA and Commercialization- -Investor Webcast Today at 8:30 a.m. ET- SAN DIEGO, Sept. 24, 2024 (GLOBE NEWSWIRE) -- Capricor Therapeutics (NASDAQ: CAPR), a biotechnology company developing transformative cell and exosome-based therapeutics for the treatment of rare diseases, announced today, following recent meetings with the U.S. Food and Drug Administration (FDA), its intent to file a Biologics License Application (BLA) based on existing cardiac and natural history data for deramiocel to treat all patients diagnosed with Duchenne muscular dystrophy (DMD) cardiomyopathy. Following the FDA meetings: Capricor plans to commence the filing of a BLA in October of 2024 seeking f
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News
- Deramiocel's Promise Brightens Capricor's Outlook, With Strings Attached [Seeking Alpha]Seeking Alpha
- Capricor Therapeutics to Present at Upcoming Investor Conferences [Yahoo! Finance]Yahoo! Finance
- Capricor Therapeutics to Present at Upcoming Investor ConferencesGlobeNewswire
- Capricor wins key EU designations for the lead asset [Seeking Alpha]Seeking Alpha
- Parent Project Muscular Dystrophy Culminates 30th Anniversary with Celebratory "Investing in Every Future" Event [Yahoo! Finance]Yahoo! Finance
CAPR
Earnings
- 11/13/24 - Miss
CAPR
Sec Filings
- 12/16/24 - Form 4
- 12/4/24 - Form 4
- 11/14/24 - Form 10-Q
- CAPR's page on the SEC website