Capricor Therapeutics said on Tuesday the U.S. Food and Drug Administration has indicated that an advisory panel review may ...

Capricor on Tuesday disclosed that the FDA has indicated that no AdCom is necessary for deramiocel’s Biologics License ...

Capricor Therapeutics (CAPR) said on Tuesday that the U.S. Food and Drug Administration is not eyeing an advisory committee ...

Capricor stock drops as FDA cancels advisory meeting on Duchenne therapy; leadership changes and regulatory tensions fuel ...

The ouster of the FDA's chief regulator of cell and gene therapies came immediately after a disagreement with her boss over a ...

Capricor Therapeutics (CAPR) announced the completion of the Food and Drug Administration’s pre-license inspection of its San Diego manufacturing facility for Deramiocel, the company’s lead cell ...

Capricor Therapeutics shares climbed Tuesday after the Food and Drug Administration said an advisory committee meeting is not required before deciding on the company's cell therapy treatment for a ...

Capricor's lead asset, deramiocel, targets DMD-related cardiomyopathy and faces key FDA milestones (ADCOM, PDUFA) in 2025. A strong cash position and partnership with Nippon Shinyaku provide ...

Nicole Verdun, MD, super office director of the FDA’s Office of Therapeutic Products (OTP) and her deputy Rachael Anatol, PhD ...

More information about these and other risks that may impact Capricor’s business is set forth in Capricor’s Annual Report on Form 10-K for the year ended December 31, 2024, as filed with the ...