Vera Therapeutics Announces Positive ORIGIN 3 Final Efficacy Analysis of TRUTAKNA™ (atacicept-vymj) in IgA Nephropathy Presented at ASN Kidney Week 2026 and Published in the New England Journal of Medicine
Key Highlights
- ➤ORIGIN 3 met its primary endpoint with statistically significant proteinuria reduction at 36 weeks
- ➤TRUTAKNA achieved significance across all prespecified endpoints, including eGFR change and annualized slope
- ➤TRUTAKNA significantly reduced composite kidney disease progression events
- ➤Serious adverse events were 7% with TRUTAKNA versus 15% with placebo
- ➤Vera plans supplemental BLA submission in Q4 2026; full FDA approval expected in 2027
Expert Statements
Jonathan Barratt, Mayer Professor of Renal Medicine, University of Leicester
“I have spent my career caring for people with IgAN, and for most of that time, our conversations were about the limited treatment options”
Jonathan Barratt, Mayer Professor of Renal Medicine, University of Leicester
“The ORIGIN 3 final efficacy results have the potential to change those conversations.”
Jonathan Barratt, Mayer Professor of Renal Medicine, University of Leicester
“In the study, TRUTAKNA achieved a physiologic rate of eGFR loss compared to the pathologic rate observed with placebo and significantly reduced the risk of composite kidney disease progression events, reflecting the potential for disease modification and kidney protection in IgAN.”
Jonathan Barratt, Mayer Professor of Renal Medicine, University of Leicester
“These results, combined with a safety profile comparable to placebo, represent a meaningful advance for patients.”
Marshall Fordyce, Founder and CEO of Vera Therapeutics
“ORIGIN 3 represents an important innovation in IgAN clinical development through our alignment with the FDA on an earlier final efficacy analysis.”
Marshall Fordyce, Founder and CEO of Vera Therapeutics
“As a physician, I value the ability to offer patients randomized to placebo an earlier opportunity to transition to open-label active treatment, while generating a robust dataset.”
Marshall Fordyce, Founder and CEO of Vera Therapeutics
“With the strength of the clinical data package, TRUTAKNA has the potential to transform the treatment landscape”
Marshall Fordyce, Founder and CEO of Vera Therapeutics
“We plan to submit the supplemental BLA in the fourth quarter of this year, and we look forward to potential FDA full approval of TRUTAKNA in 2027.”
Marshall Fordyce, Founder and CEO of Vera Therapeutics
“We reiterate our gratitude to the patients, investigators, employees, and collaborators who have helped us to deliver TRUTAKNA to patients in need.”
* TRUTAKNA, the first and only FDA-approved BAFF and APRIL inhibitor, achieved statistical significance in all prespecified endpoints, including eGFR change from baseline and annualized slope, and risk reduction in composite kidney disease progression events. * Favorable safety profile, and generally comparable to placebo. * Plan to submit supplemental BLA to the U.S. FDA in Q4 2026 for full approval expected in 2027. * Investor webcast is scheduled for October 22 at 4:30 pm EDT. BRISBANE, Calif., Oct. 22, 2026 (GLOBE NEWSWIRE) -- Vera Therapeutics, Inc. (Nasdaq: VERA), a commercial-stage biotechnology company, today announced that the final efficacy analysis for the ORIGIN 3 trial of TRUTAKNA in adults with primary IgA nephropathy (IgAN) at risk for disease progression 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.
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