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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 ...
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 ...
BioPharma Dive3d
FDA investigating Elevidys safety; Nektar shares spike on eczema data
The agency said it will evaluate whether further regulatory action is needed after investigating the deaths of two patients ...
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.
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 ...
Capricor says US FDA may not convene expert panel for co's cell therapy
Capricor Therapeutics said on Tuesday the U.S. Food and Drug Administration will not convene its panel of outside experts before deciding on the company's cell therapy for a heart condition associated ...
Capricor Therapeutics Shares Climb After FDA Says Panel Meeting Not Needed
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 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 ...
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 ...
GEN - Genetic Engineering and Biotechnology News5d
StockWatch: CGT Stocks Fall on FDA Therapeutic Products Upheaval
Nicole Verdun, MD, super office director of the FDA’s Office of Therapeutic Products (OTP) and her deputy Rachael Anatol, PhD ...
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.
Asianet Newsable on MSN7d
Capricor Stock Slumps 16% On Report Of Key FDA Executive’s Removal, But Retail’s Hopeful About New 4-Year Deramiocel Data
Capricor on Friday announced positive four-year safety and efficacy results from its ongoing mid-stage study of its cell ...