- Complete Response Letter (CRL): In July 2025, the FDA issued a CRL, declining to approve the application in its current form due to a lack of substantial evidence of effectiveness and the need for additional clinical data. The review had advanced without major issues up to that point, including a successful manufacturing inspection.
- New Data and Resubmission Plan: Capricor engaged with the FDA post-CRL and planned to use data from its ongoing Phase 3 HOPE-3 clinical trial to address the FDA's concerns.
- Positive Phase 3 Results: On December 3, 2025, Capricor announced positive topline results from the pivotal Phase 3 HOPE-3 study, which met its primary endpoint by showing a slower decline in upper limb function in patients treated with deramiocel compared to a placebo.
- Current Status: The company plans to use these new results in its resubmission to the FDA. The FDA has indicated this would be a Class 2 resubmission, which typically has a six-month review timeline.