Capricor announces initiation of rolling submission of BLA for deramiocel

Capricor Therapeutics announced today that it has initiated its rolling submission process with the U.S. Food and Drug Administration, FDA, for a Biologics License Application, BLA, seeking full approval for deramiocel to treat all patients diagnosed with Duchenne muscular dystrophy, DMD cardiomyopathy. “This announcement marks an important step in the U.S. regulatory process towards a potential Biologics License Application approval of deramiocel for the treatment of DMD,” said Linda Marban, Ph.D., Chief Executive Officer of Capricor. “An approval of deramiocel would allow us to expedite the delivery of this novel, first-in-class treatment to patients in need. We look forward to working with the FDA during this process.” Capricor plans to complete its rolling BLA submission by the end of 2024.