Capricor publishes Lancet HOPE-3 Phase 3 results; LVEF model updated, FDA BIMO inspection noted

Capricor publishes final one-year HOPE-3 Phase 3 results in The Lancet and reports an updated LVEF statistical model that changes significance for the key secondary endpoint.

Key Highlights:

• Peer-reviewed Lancet publication validates HOPE-3 design and SAP 3.0; primary endpoint met (PUL 2.0, p=0.03).
• Updated LVEF model yields p=0.09 (1.8 pp treatment diff) vs prior p=0.04 (2.4 pp); cardiomyopathy subgroup nominally significant p=0.02 (2.8 pp).
• Other type‑1 error‑controlled endpoints will be characterized as nominally significant under hierarchical testing.
• FDA conducted BIMO inspection (July 6–20, 2026); one Form FDA 483 observation on SOPs, documentation and vendor oversight; Capricor is preparing a timely response.
• Deramiocel BLA remains under active FDA review with PDUFA target action date August 22, 2026.

Original SEC Filing:

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