Cerus INTERCEPT RBC Phase 3 trial meets primary non-inferiority endpoint

CERUS CORP

AKI incidence 29.3% (INTERCEPT RBC) vs 28.0% (conventional); non-inferiority margin 14% (p=0.001).
Related TEAEs within 28 days: 2.5% vs 0.6% (p=0.130); no adverse health effects from RBC antibodies.
Modular PMA submission to FDA planned H2 2025; final module expected H2 2026 after RedeS trial.
ReCePI trial enrolled 581 patients at 18 U.S. sites; funded in part by BARDA contract.

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