Deramiocel (CAP-1002) - (HOPE-3)

July 27, 2026: Capricor Therapeutics (NASDAQ: CAPR) provided an update ahead of its upcoming FDA Advisory Committee meeting for the ongoing FDA review of its Biologics License Application (BLA) for deramiocel, an investigational allogeneic cardiac-derived cell therapy for Duchenne muscular dystrophy (DMD). The company said it has engaged with the FDA throughout the review and emphasized that its Phase 3 HOPE-3 results were governed by the final statistical analysis plan (SAP) version 3.0, finalized prior to unblinding. Capricor stated that post-hoc analyses in the FDA’s briefing materials relied on an earlier SAP version 1.1, which it described as an unsigned, incomplete internal draft that became obsolete with the addition of cohort B. Capricor said HOPE-3 showed a statistically significant benefit on the primary endpoint (PUL 2.0) with supportive benefits in cardiac function, and it posted a portion of its slides on its website to frame the advisory committee discussion.