Imlifidase significantly improved kidney function and dialysis independence in sensitized transplant patients, with FDA approval expected by late 2025.

Imlifidase met its primary goal in a U.S. Phase 3 trial for kidney transplant patients, showing significantly better kidney function at 12 months compared to controls, with a mean eGFR of 51.5 vs. 19.3 mL/min/1.73m². The treatment also improved dialysis independence and was well-tolerated in highly sensitized recipients with few transplant options. Hansa Biopharma plans to seek FDA approval by late 2025, citing the results as a potential breakthrough in a field with limited advances in decades. Full results are expected in 2026.