Hansa Biopharma Files US Biologics License Application for Kidney Transplant Desensitization Treatment

05:13 AM EST, 12/21/2025 (MT Newswires) -- Hansa Biopharma (HNSA.ST) filed for a priority review of its biologics license application for imlifidase, its desensitization treatment for adult kidney transplant patients, to the US Food and Drug Administration. The application was based on its phase 3 ConfIdeS study, which showed a significant improvement in kidney function, as well as dialysis independence at 12 months in patients using imlifidase, compared with a control arm, according to a Dec. 19 release. The Swedish specialty pharmaceutical company expects the application to possibly be approved in the third quarter of 2026.