Research & Clinical Trials
Vera Therapeutics Reports Positive Final ORIGIN 3 Efficacy Results for Trutakna in IgA Nephropathy
By News Desk ·
Key takeaways
- Vera Therapeutics presented final ORIGIN 3 efficacy results for Trutakna in IgA nephropathy at ASN Kidney Week 2026.
- The trial met all prespecified endpoints, including proteinuria reduction and eGFR change, with a safety profile comparable to placebo.
- Vera Therapeutics plans to submit a supplemental BLA to the FDA in Q4 2026, expecting full approval in 2027.
Vera Therapeutics presented final efficacy results from the ORIGIN Phase III trial of atacicept in IgA nephropathy at the ASN Kidney Week meeting, according to a Seeking Alpha transcript of the company's October 22 investor webcast. The company did not disclose specific efficacy outcomes in the transcript.
Barratt Presents ORIGIN 3 Data at ASN Kidney Week
Dr. Jonathan Barratt, the Mayer Professor of Renal Medicine at the University of Leicester and Head of the Renal Research Group, presented the data in an open plenary session, Marshall Fordyce, Vera's founder and chief executive, said on the webcast. Fordyce said he was speaking from Denver, Colorado, where the American Society of Nephrology is hosting Kidney Week.
The future of trading and TradingView each reported that Vera announced positive final efficacy results for TRUTAKNA (atacicept-vymj) in IgA nephropathy from the ORIGIN 3 trial, presented at ASN Kidney Week 2026 and published in the New England Journal of Medicine. Both outlets reported that the drug met all prespecified endpoints, including proteinuria reduction and eGFR change, with a safety profile comparable to placebo. Both reported that the company plans to submit a supplemental BLA to the FDA in Q4 2026, expecting full approval in 2027.
Vera's Regulatory and Funding Record
Vera Therapeutics is a late-stage biotechnology company developing biologic therapeutics for B-cell-mediated autoimmune kidney diseases, primarily atacicept for IgA nephropathy, according to akta.pro company records. The same records show the company aligned with the FDA in June 2026 on a revised, accelerated ORIGIN Phase 3 eGFR analysis planned for Q3 2026, pulled forward from 2027, with a planned sBLA submission in Q4 2026 and potential full approval in 2027. The records list total funding of $1.2 billion, a December 2025 post-IPO equity round of $261 million, and a valuation estimate of $1 billion to $5 billion.
Earlier ORIGIN 3 Endpoint Results
In September 2026, Simply Wall St reported that Vera said TRUTAKNA met all prespecified endpoints in the final efficacy analysis of the ORIGIN 3 trial for primary IgA nephropathy, with a 5.0 mL per year eGFR slope delta and a 76% risk reduction on a composite kidney endpoint. In August 2026, BioSpace reported that Trutakna showed stabilization in kidney function comparable to Otsuka Pharmaceuticals' Voyxact, according to data from the Phase 3 ORIGIN 3 study. Also in August 2026, Simply Wall St reported that Vera received accelerated FDA approval for TRUTAKNA to treat primary IgA nephropathy in adult patients.
Supplemental BLA Submission Planned for Q4 2026
Vera Therapeutics plans to submit a supplemental BLA to the FDA in Q4 2026, with full approval expected in 2027, according to The future of trading and TradingView.