Capricor announces positive FDA Type-B meeting confirming Phase 3 path to BLA for CAP-1002 in DMD

CAPRICOR THERAPEUTICS, INC.

FDA aligned on HOPE-3 trial design; key endpoints unchanged; BLA submission targeted for 2025.
HOPE-3 enrollment ~90% complete (52 of ~58 patients dosed); interim analysis expected Q4 2023.
Topline data for HOPE-3 expected Q4 2024; BLA supported by product from Los Angeles site.
San Diego site work continues for potential commercial demand; CAP-1002 holds Orphan Drug and RMAT designations.
Company eligible for Priority Review Voucher if CAP-1002 receives FDA approval for DMD.

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