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 ...
Why Is Capricor Therapeutics Stock Trading Lower On Monday?
Capricor stock drops as FDA cancels advisory meeting on Duchenne therapy; leadership changes and regulatory tensions fuel ...
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 has indicated that an advisory panel review may ...
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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 ...
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Disagreements over Duchenne therapy, management style may have led to ouster of key FDA official
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 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 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 ...
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Capricor Therapeutics Reports Positive Four-Year Results for Deramiocel in Duchenne Muscular Dystrophy at PPMD 2025 Annual Conference - Nasdaq
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 ...
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Capricor Therapeutics Announces Orphan Drug Designation for Becker Muscular Dystrophy and Regulatory Progress for Duchenne Muscular Dystrophy Program - Morningstar
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 ...
Capricor Therapeutics' Becker Muscular Dystrophy Drug Gets Orphan Drug Designation in U.S.
Capricor Therapeutics has received an orphan drug designation for its drug aimed at potentially treating Becker Muscular Dystrophy. The biotechnology company said Tuesday that the Food and Drug ...