Clinical Trial SuccessPositive topline Phase 3 ConfIdeS results in the U.S. demonstrated a statistically significant and clinically meaningful improvement in eGFR at 12 months and significantly less dialysis dependency.
Market ExpansionBeyond transplantation, imlifidase and next-gen IgG cleaver HNSA-5487 are advancing in autoantibody-driven autoimmune diseases such as anti-glomerular basement membrane (anti-GBM) disease and Gullain-Barre syndrome (GBS).
Regulatory ApprovalIf approved, Idefirix would become the first FDA-approved therapy to address a substantial unmet need among highly sensitized kidney transplant patients and could represent a major commercial inflection point, with the opportunity to significantly accelerate revenue growth for Hansa.