FDA accepts Hansa Biopharma BLA for imlifidase, with PDUFA date set for Dec. 19, 2026

The U.S. Food and Drug Administration (FDA) has accepted Hansa Biopharma’s Biologics License Application (BLA) for imlifidase. FDA's filing review was completed on day 60, and the PDUFA action date for the BLA is set for December 19, 2026. The BLA submission is supported by the previously communicated highly statistically significant outcome of the pivotal U.S. Phase 3 ConfIdeS trial.

The trial evaluated 12-month kidney function in highly sensitized adult kidney transplant patients (cPRA ≥99.9%) with a positive crossmatch against a deceased donor, compared to a control arm. The trial successfully met its primary endpoint, demonstrating significantly improved kidney function in the imlifidase arm at 12 months as measured by mean estimated glomerular filtration rate (eGFR) (p < 0.0001). A key secondary endpoint, dialysis independence at 12 months, was also statistically significant in favor of imlifidase (p = 0.0007). Imlifidase was generally well tolerated, with a safety profile consistent with previous clinical trial experience.

ConfIdeS is a pivotal Phase 3 open label, randomized, controlled trial of imlifidase in kidney transplantation. The trial evaluated kidney function at 12 months in 64 highly sensitized kidney transplant patients with positive crossmatch against a deceased donor, comparing desensitization using imlifidase with a control arm. A total of 25 U.S. sites participated in the trial, and the total trial duration is five years, which includes a long-term follow-up agreed with the FDA as part of the accelerated approval pathway.

Imlifidase is a unique IgG-cleaving enzyme that rapidly inactivates more than 95% of donor-specific antibodies within 2-6 hours of administration, providing a crucial window to enable HLA-incompatible kidney transplantation. The treatment is conditionally approved in the European Union, Norway, Liechtenstein, Iceland and the UK under the tradename IDEFIRIX, and is also approved in Australia and Switzerland.

In its first-quarter 2026 update, the company said preparations for a potential U.S. launch progressed in parallel. The results from the ConfIdeS pivotal U.S. Phase 3 trial have been accepted as an oral presentation at the American Transplant Congress in Boston in June 2026.

First-quarter revenue totalled 34.6 MSEK compared to 66.3 MSEK in Q1 2025, while IDEFIRIX product sales reached 33.9 MSEK compared to 65.7 MSEK. On March 19, 2026, the company entered into a USD 30.0 million convertible note purchase agreement with Athyrium Capital Management. Including the convertible note, cash and cash equivalents on March 31, 2026, totalled 676.5 MSEK, or approximately USD 73.2 million.