Capricor Therapeutics Announces Key Regulatory Updates for its Duchenne Muscular Dystrophy Program [Yahoo! Finance]
Capricor Therapeutics, Inc. (CAPR)
Last capricor therapeutics, inc. earnings: 3/18 04:01 pm
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Source: Yahoo! Finance
Advisory Committee meeting scheduled for July 30, 2025 Mid-cycle meeting recently completed with no significant issues or major deficiencies; late-cycle meeting planned for mid-July Biologics License Application remains under priority review with PDUFA target action date of August 31, 2025 SAN DIEGO, June 11, 2025 (GLOBE NEWSWIRE) -- Capricor Therapeutics (NASDAQ: CAPR), a biotechnology company developing transformative cell and exosome-based therapeutics for the treatment of rare diseases, today announced the successful completion of the U.S. Food and Drug Administration's (FDA) Pre-License Inspection (PLI) of its San Diego manufacturing facility for Deramiocel, the Company's lead cell therapy candidate with a Biologics License Application (BLA) under FDA review for potential approval in the treatment of Duchenne Muscular Dystrophy (DMD). The inspection concluded with a Form 483 containing several observations. The Company has submitted its responses to the FDA, none of which
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CAPR
News
- INVESTOR ALERT: Pomerantz Law Firm Investigates Claims On Behalf of Investors of Capricor Therapeutics, Inc. - CAPRGlobeNewswire
- INVESTOR ALERT: Pomerantz Law Firm Investigates Claims On Behalf of Investors of Capricor Therapeutics, Inc. - CAPRPR Newswire
- INVESTOR ALERT: Pomerantz Law Firm Investigates Claims On Behalf of Investors of Capricor Therapeutics, Inc. - CAPRGlobeNewswire
- INVESTOR ALERT: Pomerantz Law Firm Investigates Claims On Behalf of Investors of Capricor Therapeutics, Inc. - CAPRPR Newswire
- INVESTOR ALERT: Pomerantz Law Firm Investigates Claims On Behalf of Investors of Capricor Therapeutics, Inc. - CAPRGlobeNewswire
CAPR
Earnings
- 5/13/25 - Miss
CAPR
Sec Filings
- 6/16/25 - Form S-8
- 5/27/25 - Form 8-K
- 5/14/25 - Form 10-Q
- CAPR's page on the SEC website