Vera Therapeutics TRUTAKNA (Atacicept-Vymj) Meets All Prespecified Endpoints in Phase 3 ORIGIN 3 Final Efficacy Analysis in IgA Nephropathy: 76% Reduction in Composite Kidney Progression Over 104 Weeks in 428 Patients
Vera Therapeutics (NASDAQ: VERA) announced Tuesday September 15, 2026 that TRUTAKNA (atacicept-vymj, self-administered BAFF and APRIL dual inhibitor) met all prespecified endpoints in the Phase 3 ORIGIN 3 final efficacy analysis in adults with primary IgA nephropathy at risk for disease progression. The trial enrolled 428 patients. Two-year (104-week) results: TRUTAKNA stabilized kidney function (estimated glomerular filtration rate) over 52 weeks versus marked decline on placebo, and produced a 76% reduction in composite kidney disease progression events over 104 weeks. Zero patients on TRUTAKNA had dialysis, transplant, or death events versus 8 events in the placebo arm. eGFR outcomes aligned with KDIGO goals to slow kidney function decline to physiologic rates, supported by statistically significant improvements in proteinuria, galactose-deficient IgA1, and hematuria. Safety was comparable to placebo. TRUTAKNA already carries FDA accelerated approval to reduce proteinuria in IgAN at risk for progression; Vera plans a supplemental Biologics License Application (sBLA) submission for full approval in Q4 2026. Early launch metrics: more than 350 patient start forms in the first 10 weeks. TRUTAKNA competes in a rapidly evolving IgAN market alongside Novartis's Fabhalta (iptacopan) and Otsuka's Filspari (sparsentan).