FDA granted traditional approval to Novartis' Fabhalta (iptacopan) for IgA nephropathy. Phase 3 APPLAUSE-IgAN data showed eGFR decline slowed by 48% versus placebo over two years.
Vera Therapeutics and the FDA aligned on an earlier ORIGIN 3 eGFR analysis plan to support potential full approval of atacicept for IgA Nephropathy, with results now expected in Q3 2026. The company plans to submit a supplemental BLA in Q4 2026 following positive results. The pivotal trial previously met its primary endpoint with a 46% reduction in proteinuria.
New research demonstrates machine learning can optimize drug dosing, identifies biomarkers of treatment response, and validates prognostic criteria for long-term kidney survival in pediatric lupus nephritis patients.
New research highlights circulating tumor DNA as a prognostic tool in early-stage triple-negative breast cancer, while leronlimab demonstrates long-term survival signals in heavily pretreated metastatic patients through CCR5 receptor blockade.
