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Tuesday, Cerus Corporation (NASDAQ:CERS) announced topline results for the ReCePI Phase 3 trial of pathogen-reduced INTERCEPT Red Blood Cells (INTERCEPT RBCs) transfused to complex cardiac surgery patients.
The INTERCEPT Blood System for Red Blood Cells is designed to inactivate blood-borne pathogens and donor leukocytes in RBCs intended for transfusion.
The trial met its primary efficacy endpoint, demonstrating non-inferiority for INTERCEPT RBCs compared to conventional RBCs as measured by the incidence of acute kidney injury (AKI) following transfusion of study RBCs.
AKI is a sensitive transfusion efficacy indicator of RBC tissue oxygen delivery.
In transfused subjects, by modified intent to treat (mITT pre-specified primary endpoint population) the incidence of AKI was 29.3% (46/157) for INTERCEPT RBC recipients compared to 28.0% (45/161) for conventional RBC recipients, demonstrating non-inferiority of INTERCEPT RBCs compared to conventional RBCs with an upper limit of the 95% confidence interval of 10.4% compared with a non-inferiority margin of 14.0% (p = 0.001).
The safety endpoint of the proportion of patients with any related treatment-emergent adverse events within 28 days of last transfusion was not significantly different for INTERCEPT RBCs (2.5%) compared to conventional RBCs (0.6%) (p = 0.130).
“We continue to look forward to completing the RedeS clinical trial, Cerus’ ongoing pivotal Phase 3 clinical trial for INTERCEPT RBCs enrolling a broader patient population requiring RBC transfusion for acute and chronic anemia,” stated Richard Benjamin, Cerus’ chief medical officer.
Cerus anticipates initiating a modular PMA application to the FDA in the second half of 2025, with the final PMA module submission planned for the second half of 2026 upon the anticipated completion of the RedeS clinical trial.
Price Action: CERS shares are up 3.23% at $1.91 on the last check Tuesday.
Photo by Narupon Promvichai from Pixabay
Posted In: CERS
