
Capricor Therapeutics recently joined PPMD for a community webinar to provide an update on their novel cell therapy, deramiocel (formerly CAP-1002), targeting cardiomyopathy in individuals living with Duchenne. The Capricor team discussed their ongoing Biologics License Application (BLA) process with the U.S. Food and Drug Administration (FDA), highlighting the FDA’s acceptance and priority review of the BLA, which seeks full approval for deramiocel. They also shared insights from the Phase 2 HOPE-2 and HOPE-2 Open Label Extension trials, demonstrating deramiocel’s potential to decrease inflammation and fibrosis while promoting muscle regeneration. If approved, deramiocel would become the first Duchenne-specific therapy for cardiomyopathy, offering a new therapeutic option for individuals diagnosed with this condition.