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BioWorld - Friday, December 12, 2025
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» Capricor gets CRL for cell therapy BLA in rare disease
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Capricor gets CRL for cell therapy BLA in rare disease
July 11, 2025
By
Lee Landenberger
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Capricor Therapeutics Inc. received a complete response letter (CRL) from the U.S. FDA on the BLA for deramiocel to treat cardiomyopathy in Duchenne muscular dystrophy patients. The company’s CEO said the letter was unexpected.
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