Vera's ORIGIN 3 Final Analysis Reports Positive IgAN Results for TRUTAKNA, Pending FDA Full-Approval Filing

On the opening plenary stage of the American Society of Nephrology's Kidney Week 2026, Vera Therapeutics presented the final efficacy analysis of its ORIGIN 3 trial. It was a featured late-breaking oral presentation, and the results were published in The New England Journal of Medicine at the same moment. The company, based in Brisbane, California and listed on Nasdaq as VERA, announced the news on October 22, 2026.

The trial tested TRUTAKNA (atacicept-vymj) in adults with primary IgA nephropathy who are at risk of disease progression. IgAN is a serious, progressive, immune-mediated kidney disease and a leading cause of chronic kidney disease and kidney failure worldwide. About 2.5 adults per 100,000 are diagnosed each year, most often between ages 30 and 40. At least half of patients may progress to kidney failure or death within 10 to 20 years of diagnosis, and the disease can ultimately require dialysis or a transplant.

ORIGIN 3 had already met its primary endpoint, a statistically significant reduction in proteinuria at 36 weeks. In the final analysis, Vera says the drug reached statistical significance on every prespecified endpoint. These include the change in eGFR from baseline, the annualized eGFR slope, and the risk of composite kidney disease progression events. It also produced significant reductions in urine protein-to-creatinine ratio, galactose-deficient IgA1, and hematuria.

The safety figures were reported in detail. Adverse events occurred in 160 of 214 patients on TRUTAKNA (75%) and 167 of 214 on placebo (78%). Serious adverse events came in at 7% in the TRUTAKNA group against 15% in the placebo group. Infection rates were close: 51.4% on the drug and 52.3% on placebo. The company reports no clinically relevant hypogammaglobulinemia or opportunistic infections, and no clinically meaningful effect of anti-drug antibodies on efficacy or overall safety. One patient died in the placebo group; none died in the TRUTAKNA group.

Jonathan Barratt, Mayer Professor of Renal Medicine at the University of Leicester, said that for most of his career conversations with IgAN patients centered on limited options. He said the results could change that, noting that TRUTAKNA achieved a physiologic rate of eGFR loss, whereas the placebo group showed a pathologic rate.

Marshall Fordyce, Vera's founder and CEO, pointed to an unusual feature of the trial's design: the company aligned with the FDA on an earlier final efficacy analysis. In his telling, that let patients randomized to placebo move sooner to open-label active treatment while still producing a robust dataset.

TRUTAKNA is described as the first and only FDA-approved drug that inhibits both BAFF and APRIL, cytokines that activate B cells and drive IgAN. It is a 150 mg, 1 ml, once-weekly autoinjector that patients use at home. Its current approval is accelerated, based on proteinuria reduction, and it is not yet established that it slows long-term kidney function decline. In prescribing information, infections were reported in 32% of treated patients versus 28% on placebo, and local administration reactions in 30% versus 5%. Eligible commercially insured patients may pay as little as $0 through the company's copay program.

The efficacy and safety claims come from Vera's own announcement. Vera plans to submit a supplemental biologics license application to the FDA in the fourth quarter of 2026, with full approval hoped for in 2027. An investor webcast was set for 4:30 pm Eastern the same day.