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 Therapeutics updates on Deramiocel BLA for duchenne muscular dystrophy: San Diego Thursday, June 26, 2025, 15:30 Hrs [IST] Capricor Therapeutics, a biotechnology company ...

Shares of Capricor Therapeutics (CAPR) tumbled 16% on Friday morning following reports that Nicole Verdun, director of the ...

Four-year data show preservation of cardiac function, including LVEFSkeletal muscle disease progression continues to slow ...

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.

The U.S. Food and Drug Administration is due to review data on deramiocel, a cell therapy up for approval for heart disease ...

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' rating was downgraded amid FDA inspection risks, regulatory uncertainty, and potential delays in approval for deramiocel. Read more on CAPR stock here.

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.

FDA has indicated that an Advisory Committee meeting is not required at this time In-person late-cycle review meeting scheduled for mid-July Biologics License Application (BLA) remains under Priority ...