News

Capricor’s deramiocel moves ahead without AdCom, says H.C. Wainwright
Capricor on Tuesday disclosed that the FDA has indicated that no AdCom is necessary for deramiocel’s Biologics License ...
Stocktwits on MSN7d
Capricor Stock Slumps 16% On Report Of Key FDA Executive’s Removal, But Retail’s Hopeful About New 4-Year Deramiocel Data
Shares of Capricor Therapeutics (CAPR) tumbled 16% on Friday morning following reports that Nicole Verdun, director of the ...
Stocktwits on MSN3d
Capricor Therapeutics Says FDA May Not Hold Advisory Committee Meeting For DMD Therapy Approval: Stock Soars But Analyst Issues Warning
Capricor Therapeutics (CAPR) said on Tuesday that the U.S. Food and Drug Administration is not eyeing an advisory committee ...
Morningstar3d
Capricor Therapeutics Provides Regulatory Update on Deramiocel BLA for Duchenne Muscular Dystrophy - Morningstar
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 Therapeutics Announces Positive 4-Year Data from HOPE-2 Open-Label Extension Study of Deramiocel in Duchenne Muscular Dystrophy
Four-year data show preservation of cardiac function, including LVEFSkeletal muscle disease progression continues to slow ...
Pharmabiz1d
Capricor Therapeutics updates on Deramiocel BLA for duchenne muscular dystrophy
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 ...
Muscular Dystrophy News3d
FDA advisory committee meeting for deramiocel in DMD set for July
The U.S. Food and Drug Administration is due to review data on deramiocel, a cell therapy up for approval for heart disease ...
Nasdaq7d
Capricor Therapeutics Reports Positive Four-Year Results for Deramiocel in Duchenne Muscular Dystrophy at PPMD 2025 Annual Conference - Nasdaq
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 Skips Advisory Committee For Capricor's Duchenne Cell Therapy
Capricor's DMD therapy Deramiocel is under FDA Priority Review with no major issues flagged; PDUFA date set for August 31, 2025.
Capricor: A Hold Rating With Regulatory FDA Form Given For Deramiocel Advancement
Capricor Therapeutics' rating was downgraded amid FDA inspection risks, regulatory uncertainty, and potential delays in approval for deramiocel. Read more on CAPR stock here.
Capricor Reports 4-Year Data For Deramiocel, Shows Sustained Benefit In Duchenne Patients
Capricor shares four-year data showing Deramiocel slowed DMD progression and preserved function, with maintained safety in long-term use.
Capricor Therapeutics Provides Regulatory Update on Deramiocel BLA for Duchenne Muscular Dystrophy
FDA has indicated that an Advisory Committee meeting is not required at this timeIn-person late-cycle review meeting ...