Tag Archive for: imlifidase

PDUFA Action Date for Hansa Biopharma’s Imlifidase BLA Set for December 19, 2026

If approved, imlifidase will be the first treatment to address highly sensitized patients awaiting kidney transplantation. Lund, Sweden, 4 March 2026. Hansa Biopharma AB, (“Hansa” or “the Company”), (Nasdaq Stockholm: HNSA), today announced that the Food and Drug Administration (FDA) has notified the company that the previously accepted Biologics License Application (BLA) for imlifidase has been […]

Hansa Biopharma Reports Fourth Quarter and Full-Year 2025 Financial Results

· Strong Q4 with 76.0 MSEK in revenue, up 135% from Q4 2024. · Submission of Biologics License Application (BLA) for imlifidase for highly sensitized patients awaiting kidney transplantation. · Successfully completed a directed share issue raising 671.5 MSEK (~ $71.3M). Lund, Sweden, 11 February 2026. Hansa Biopharma AB, “Hansa” (Nasdaq Stockholm: HNSA), today announced its […]

Hansa hosts call with distinguished transplant surgeons: Insights on clinical practice and imlifidase Phase 3 Results

Lund, Sweden, 29 October 2025. Hansa Biopharma AB, “Hansa” (Nasdaq Stockholm: HNSA) today announced that it will host a virtual event featuring two distinguished transplant surgeons; Professor Robert Montgomery from NYU Langone Transplant Institute and Professor Matthew Cooper from the Medical College of Wisconsin, to provide deeper insights into the medical journey of highly sensitized […]

Imlifidase successfully meets primary endpoint in pivotal US Phase 3 ConfIdeS trial in kidney transplantation

At 12 months, mean eGFR was 51.5 mL/min/1.73m2 in the imlifidase arm versus 19.3 mL/min/1.73m2 in the control arm with a statistically significant and clinically meaningful difference of 32.2 mL/min/1.73m2 ( p<0.0001) Imlifidase was generally well tolerated with a safety profile consistent with previous clinical trial experience Submission of a Biologic License Application (BLA) under accelerated approval pathway […]