FDA has indicated that an Advisory Committee meeting is not required at this timeIn-person late-cycle review meeting ...

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

Deramiocel consists of allogeneic cardiosphere-derived cells (CDCs), a rare population of cardiac cells that have been shown in preclinical and clinical studies to exert potent immunomodulatory and ...

Deramiocel is an Investigational New Drug (IND) and is not yet approved for any indications. Neither BMD nor any of Capricor’s exosome-based candidates have been approved for clinical use.

Capricor's DMD therapy Deramiocel is under FDA Priority Review with no major issues flagged; PDUFA date set for August 31, 2025.

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

Capricor Therapeutics (CAPR) provided regulatory updates related to its Biologics License Application, BLA, for Deramiocel, the Company’s lead ...

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

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 ...

H.C. Wainwright characterized last week’s stock volatility as an "overreaction" and continues to view the current situation as a buying opportunity ahead of deramiocel’s August 31 PDUFA date ...