INTERCEPT - (RedeS)

November 2, 2026: Cerus Corporation (NASDAQ: CERS) reported positive topline Phase 3 RedeS (NCT03037164) results for INTERCEPT Red Blood Cells in patients requiring transfusion support. The trial met its primary efficacy endpoint, showing non-inferiority versus conventional RBCs on adjusted hemoglobin increment: 1.996 g/dL (N=195) for INTERCEPT vs 2.050 g/dL (N=199) for control, estimated difference -0.054 g/dL (95% CI, -0.210 to 0.103), with the lower CI bound above the prespecified non-inferiority margin of -0.32 g/dL (p=0.004).

For safety, related TEAEs occurred in 3.4% (9/267) of the INTERCEPT arm vs 2.5% (7/276) of control, with no statistically significant difference (p=0.634). INTERCEPT RBC-specific antibodies were seen in 2.2% (6/267) of treated subjects vs 0 in control (p<0.013), but were described as low titer and transient, with no evidence of hemolysis or clinical impact.

Cerus said full results, including secondary endpoints, are planned for submission to a peer-reviewed journal and presentation at upcoming scientific meetings. The INTERCEPT red blood cell system remains investigational in the U.S.; FDA has not yet reviewed the final RedeS clinical study report, and no approval timing was provided. The product is under regulatory review in Europe.