24/7 Market News- Capricor Therapeutics Intends to File BLA for Full Approval of Deramiocel for DMD Treatment

September 24, 2024

DENVER, Colo., Sep 24, 2024 (247marketnews.com)- Capricor Therapeutics (NASDAQ: CAPR) stated that it intends to file a Biologics License Application (BLA), based on Deramiocel’s existing cardiac and natural history data, to treat all patients diagnosed with Duchenne muscular dystrophy (DMD) cardiomyopathy, following its recent meetings with the U.S. Food and Drug Administration (FDA).

Capricor plans to begin the BLA filing process in October of 2024 and expects full submission this year.

Linda Marbán, Ph.D., Capricor’s CEO, commented, “There are currently no approved therapies for DMD cardiomyopathy, which is the leading cause of death in those with Duchenne. Based on the strength of our cardiac data, combined with the FDA’s commitment to advancing therapeutics for the treatment of rare diseases, we are seeking approval for the cardiomyopathy associated with DMD and will look to expand the label for skeletal muscle myopathy post-approval.

“This approach is the result of multiple in-depth meetings with FDA where we showed robust and positive cardiac data from our HOPE-2 and HOPE-2 OLE studies compared to natural history data from a large cohort of patients.

“Deramiocel has shown in multiple clinical trials attenuation of the cardiac implications of DMD. Based on the totality of evidence of the safety and efficacy data deramiocel has shown, we believe this is the best path forward to potential approval, allowing us to bring this novel, first-in-class treatment to patients in need in the most expeditious manner. We want to extend our appreciation to the patients, their families and advocates who continue to work with us and to the FDA for their commitment to accelerating treatments for DMD.”

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