TRUTAKNA Shows Efficacy in Treating IgA Nephropathy

BRISBANE, Calif., Oct. 22, 2026 /CourierPR/ -- Vera Therapeutics, a commercial-stage biotechnology company, today announced significant results from the ORIGIN 3 trial of TRUTAKNA™ (atacicept-vymj), the first and only FDA-approved BAFF and APRIL inhibitor, in adults with primary Immunoglobulin A (IgA) nephropathy (IgAN) at risk for disease progression. The trial, which was presented as a featured late-breaking oral presentation during the opening plenary session of the American Society of Nephrology (ASN) Kidney Week 2026 and simultaneously published in The New England Journal of Medicine, achieved statistical significance in all prespecified endpoints, including a 36-week significant proteinuria reduction and a 7% rate of serious adverse events compared to 15% in the placebo group.

TRUTAKNA, a B-cell activating factor (BAFF) and A proliferation-inducing ligand (APRIL) inhibitor, demonstrated favorable safety profile, with a rate of serious adverse events in the TRUTAKNA group being 7% compared to 15% in the placebo group. The most common adverse reactions in patients treated with TRUTAKNA and placebo were infections (32% vs 28%) and local administration reactions (30% vs 5%). The most common infection was upper respiratory tract infection, and the most common local administration reactions were injection site reaction and injection site erythema.

The final efficacy analysis of the ORIGIN 3 trial met the primary endpoint of statistically significant proteinuria reduction at 36 weeks. In the final efficacy analysis, TRUTAKNA achieved statistical significance in all prespecified endpoints, including reductions in urine-protein to creatinine ratio, galactose-deficient IgA1, and hematuria. TRUTAKNA was well tolerated with a favorable safety profile generally comparable to placebo, consistent with previous safety data from the ORIGIN program.

The company plans to submit a supplemental BLA to the U.S. FDA in Q4 2026 for full approval expected in 2027. An investor webcast is scheduled for October 22 at 4:30 pm EDT. The live webcast will be available on the Company’s Investor Calendar, with the recording and presentation available immediately following the event.

TRUTAKNA, a self-administered at-home, small-volume (1 ml), 150 mg once-weekly autoinjector, is indicated to reduce proteinuria in adults with primary IgA nephropathy at risk for disease progression. The indication is approved under accelerated approval based on reduction of proteinuria. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory clinical trial.

Vera Therapeutics, founded in 2016 and based in Brisbane, California, is a commercial-stage biotechnology company focused on the pursuit of truth in science to transform medicine in autoimmune disease, starting with the kidney. The company's flagship commercial product is TRUTAKNA (atacicept-vymj), a BAFF and APRIL inhibitor indicated to reduce proteinuria in adults with primary IgA nephropathy at risk for disease progression. Beyond IgAN, Vera Therapeutics is evaluating additional diseases where the reduction of autoantibodies through inhibition of BAFF and APRIL may prove clinically meaningful.

Vera Therapeutics will host an investor call and webcast to discuss the trial results at 4:30 PM EST on October 22. To register, click here.

Vera Therapeutics is a commercial-stage biotechnology company focused on the pursuit of truth in science to transform medicine in autoimmune disease, starting with the kidney. The company's flagship commercial product is TRUTAKNA (atacicept-vymj), a BAFF and APRIL inhibitor indicated to reduce proteinuria in adults with primary IgA nephropathy at risk for disease progression. Beyond IgAN, Vera Therapeutics is evaluating additional diseases where the reduction of autoantibodies through inhibition of BAFF and APRIL may prove clinically meaningful. Vera Therapeutics was founded in 2016 and is based in Brisbane, California.