Capricor expects to submit updates to BLA in February 2026

Capricor Therapeutics (CAPR) provided a regulatory update regarding its Biologics License Application, BLA, for Deramiocel, the Company’s investigational first-in-class cell therapy for the treatment of Duchenne muscular dystrophy, DMD. As previously disclosed, the Company provided topline results from its Phase 3 HOPE-3 clinical study to the U.S. Food and Drug Administration, FDA, in late 2025. Following its review of these data, the FDA has formally requested the full HOPE-3 clinical study report, CSR, and supporting data to address the Complete Response Letter, CRL. The FDA did not request any additional clinical studies or new patient data as part of this request. Preparation of the HOPE-3 CSR is well underway, and the Company plans to submit the requested materials to the FDA in February 2026. The Company expects that this submission will address the items outlined in the CRL and support continued review of the BLA, including the assignment of a new Prescription Drug User Fee Act target action date.