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Capricor Therapeutics ( (CAPR) ) has shared an announcement.
Capricor Therapeutics is set to file a Biologics License Application for deramiocel, a promising treatment for Duchenne muscular dystrophy cardiomyopathy, after encouraging discussions with the FDA. The application, which leverages existing cardiac data and natural history studies, will begin in October 2024 with full approval sought for treating all DMD cardiomyopathy patients. Additionally, the company is eyeing a post-approval expansion of the treatment to DMD skeletal muscle myopathy, opting to combine trial cohorts for a more robust study and delaying the unblinding of certain data. This strategy underscores Capricor’s commitment to fast-tracking a novel treatment for a disease with no approved therapies for its cardiac complications.
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