Capricor Therapeutics Announces Initiation of Rolling Submission of Biologics License Application (BLA) with U.S. FDA for Deramiocel for the Treatment of Duchenne Muscular Dystrophy
Capricor Therapeutics, Inc. (CAPR)
Last capricor therapeutics, inc. earnings: 3/18 04:01 pm
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Source: GlobeNewswire
-Company Plans to Complete Rolling BLA Submission by End of 2024; Application May be Eligible for Priority Review by FDA- SAN DIEGO, Oct. 09, 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 that it has initiated its rolling submission process with the U.S. Food and Drug Administration (FDA) for a Biologics License Application (BLA), seeking full approval for deramiocel to treat all patients diagnosed with Duchenne muscular dystrophy (DMD) cardiomyopathy. “This announcement marks an important step in the U.S. regulatory process towards a potential Biologics License Application approval of deramiocel for the treatment of DMD,” said Linda Marbán, Ph.D., Chief Executive Officer of Capricor. “An approval of deramiocel would allow us to expedite the delivery of this novel, first-in-class treatment to patients in need. We look forward to
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- 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
- Capricor Therapeutics Granted Orphan Drug and ATMP Status for Deramiocel by European Medicines Agency [Yahoo! Finance]Yahoo! Finance
- Capricor Therapeutics Granted Orphan Drug and ATMP Status for Deramiocel by European Medicines AgencyGlobeNewswire
- Capricor Therapeutics Third Quarter 2024 Earnings: Misses Expectations [Yahoo! Finance]Yahoo! Finance
CAPR
Earnings
- 11/13/24 - Miss
CAPR
Sec Filings
- 11/14/24 - Form 10-Q
- 11/13/24 - Form 8-K
- 11/12/24 - Form SC
- CAPR's page on the SEC website