Hansa Biopharma Completes Randomization in Pivotal Phase 3 US ConfIdeS Trial
Lund, Sweden, 31 May, 2024. Hansa Biopharma AB, (“Hansa” or the “Company”) (Nasdaq Stockholm: HNSA), today announced recruitment and randomization in its US ConfIdeS trial is complete. ConfIdeS is a pivotal Phase 3 open label, randomized, controlled trial of imlifidase in kidney transplantation. Data from the trial is expected to support a Biologic License Application (BLA) submission under the accelerated approval pathway to the US Food and Drug Administration (FDA) in the second half of 2025. Søren Tulstrup, President and CEO, Hansa Biopharma said, “The randomization of 64 patients in