Capricor's HOPE-3 Deramiocel data published in The Lancet; LVEF p-value revised to 0.09; FDA BIMO inspection cited

CAPRICOR THERAPEUTICS, INC.

HOPE-3 Phase 3 results published in The Lancet; primary endpoint met: 54% slowing of upper limb decline (PUL 2.0, p=0.03).
LVEF secondary endpoint p-value revised to 0.09 (1.8 ppt difference) from previously reported 0.04 (2.4 ppt) under updated statistical model.
FDA BIMO inspection (July 6-20) resulted in Form 483 observation on SOPs, documentation, vendor oversight; company says data integrity unaffected.
Deramiocel BLA under FDA review with PDUFA target action date of August 22, 2026.
Pre-specified cardiomyopathy subgroup showed nominally significant LVEF benefit (p=0.02, 2.8 ppt difference).

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