Vera's TRUTAKNA hits all endpoints in ORIGIN 3 final analysis for IgA nephropathy

Vera Therapeutics announced on September 15, 2026 that TRUTAKNA met all prespecified endpoints of the final efficacy analysis of the ORIGIN 3 trial in adults with primary IgA nephropathy (IgAN) at risk for disease progression.¹ The results come from topline results from the final analysis set of 428 patients.¹

In the trial, mean eGFR change from baseline at 52 weeks was -0.1 for TRUTAKNA versus -5.7 for placebo, a treatment effect of 5.6 (p<0.0001), and the composite kidney disease progression event occurred in 11 patients on TRUTAKNA versus 38 on placebo, representing a hazard ratio of 0.24 and a 76% risk reduction (p<0.0001).¹ Additionally, no patients on TRUTAKNA experienced dialysis of at least 30 days, transplant, or death through 104 weeks, compared with 8 patients on placebo.¹

On safety, TRUTAKNA was well tolerated with a favorable safety profile generally comparable to placebo, consistent with previous results from the ORIGIN program, with similar rates of overall adverse events and infections between groups and no opportunistic infections or clinically relevant hypogammaglobulinemia.¹

The company said it plans to submit a supplemental BLA to the FDA for full approval in Q4 2026.¹ CEO Marshall Fordyce said the company looks forward to the potential full approval of TRUTAKNA in 2027.¹

On the commercial side, Vera reported over 350 patient start forms generated in the first ten weeks¹ of launch. TRUTAKNA currently holds accelerated approval to reduce proteinuria in adults with primary IgAN at risk for disease progression, based on reduction of proteinuria,¹ and continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory clinical trial.¹ Detailed data from the final analysis are expected to be presented at an upcoming scientific congress.¹