TRUTAKNA (atacicept-vymj) - (ORIGIN 3)

Sept. 15, 2026: Vera Therapeutics (NASDAQ: VERA) reported final Phase 3 ORIGIN 3 results for TRUTAKNA (atacicept-vymj) in 428 adults with primary IgA nephropathy at risk for progression. TRUTAKNA met all prespecified endpoints versus placebo: mean eGFR change at 52 weeks was -0.1 vs -5.7 mL/min/1.73m2 (treatment effect 5.6; p<0.0001); annualized eGFR slope through 104 weeks was -0.6 vs -5.6 (effect 5.0; p<0.0001); and composite kidney disease progression events through 104 weeks were 11 vs 38 (HR 0.24, 95% CI 0.12-0.48), a 76% risk reduction (p<0.0001). Dialysis for at least 30 days, transplant, or death occurred in 0 patients on TRUTAKNA vs 8 on placebo.

The company said hierarchically tested endpoints of proteinuria, galactose-deficient IgA1, and hematuria were also significantly improved. Safety was described as favorable and generally comparable to placebo, with similar overall adverse event and infection rates and no opportunistic infections or clinically relevant hypogammaglobulinemia.

TRUTAKNA is already under accelerated approval to reduce proteinuria in adults with primary IgAN. Vera plans to submit a supplemental BLA for full approval in Q4 2026 and said detailed final ORIGIN 3 results will be presented at an upcoming scientific congress.