Shots:
- Hansa Biopharma has reported topline P-III (ConfIdeS) trial data assessing imlifidase vs control for 12mos. in 64 kidney transplant pts (cPRA ≥99.9%) across 25 US sites
- Trial met its 1EP of improved kidney function at 12mos. per mean eGFR, with pts achieving eGFR of 51.5 mL/min/1.73m2 vs 19.3 mL/min/1.73m2, plus reached statistical significance in dialysis independence at 12mos. (2EP); full data to be presented in a 2026 conference
- Additionally, Imlifidase is planned for submission to the US FDA under the accelerated approval pathway by the end of 2025
Ref: Hansa Biopharma | Image: Hansa Biopharma | Press Release
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