When the FDA approved TRUTAKNA for IgA nephropathy in July, the label carried a sentence that Vera Therapeutics needed this week's data to remove: it had not been established whether the drug slows long-term kidney function decline.
The final ORIGIN 3 analysis, reported September 15, is the company's answer. In the 428-patient confirmatory trial, 11 patients on TRUTAKNA, known chemically as atacicept, reached a composite kidney disease progression endpoint through 104 weeks, against 38 on placebo, a hazard ratio of 0.24 and a 76 percent risk reduction. The endpoint's confirmed components are the ones that matter most to patients: dialysis for 30 days or more, kidney transplant, or death, where the tally was zero on treatment against eight on placebo. Kidney function held essentially flat on treatment, with eGFR falling 0.1 mL/min/1.73m² at 52 weeks against a 5.7 decline on placebo, and the two-year eGFR slope showing an annual decline of 0.6 against 5.6, a difference the company frames as meeting the goal of keeping decline below 1 mL/min/1.73m² per year.
The data arrived on schedule. Vera disclosed in June that the FDA had aligned on an earlier analysis plan, pulling the eGFR readout forward to the third quarter, with a supplemental biologics application planned for the fourth quarter seeking full approval. A decision would then be possible in 2027. The July accelerated approval rested on the 36-week interim proteinuria result, a 45.7 percent reduction from baseline against 6.8 percent on placebo, and the label's conditional language reflected exactly that: the agency accepted proteinuria as a surrogate while requiring confirmatory verification that the effect on kidney function is real.
The confirmation, and its caveats
The two-year result is the strongest dataset in the class, with the caveats that attach to any company-reported readout. The numbers come from a press release and SEC filing, not a peer-reviewed publication or a presented congress abstract, and the detailed 104-week values for proteinuria, galactose-deficient IgA1 and hematuria have not been published. The interim values, which were the approval basis, were substantial: a 41.8 percentage point advantage on urine protein reduction and hematuria resolution in 81 percent of treated patients against 20.7 percent on placebo. The safety profile at two years was broadly comparable to placebo, with infections in 32 percent of treated patients against 28 percent, injection site reactions driving the difference in local tolerability, and no opportunistic infections or clinically relevant hypogammaglobulinemia observed. The label warns of immunosuppression and increased infection risk, as expected for a drug that suppresses the antibody-producing immune cells believed to drive the disease.
Atacicept itself is a story of persistence. The molecule was first developed two decades ago, passed through Merck KGaA's hands after failures in multiple sclerosis and lupus, and was licensed to Vera in 2020 for a package of milestone payments and royalties. It is the only approved drug that blocks both BAFF and APRIL, the two signals that drive the production of the abnormal IgA antibodies at the center of IgA nephropathy.
A crowded race with a clock
The confirmatory data lands in a market that has filled in fast. Six products now compete across five mechanisms: Tarpeyo, Filspari, Novartis's Fabhalta and Vanrafia, Otsuka's Voyxact, and TRUTAKNA itself, priced at about $425,000 per year at list. Vera reported more than 350 patient start forms in the first ten weeks after launch. The most direct threat arrives on a known date: Vertex's povetacicept, a dual BAFF/APRIL inhibitor in the same mechanism class, has a PDUFA date of November 30, 2026, and Phase III data showing a 52 percent urine protein reduction. A head-to-head competition between two drugs with similar biology will now be decided by the fine print of their labels, their safety profiles, and which full-approval data set convinces nephrologists first.
The market's reaction to the readout was a useful summary of what remains unresolved. The stock rose in premarket trading and reversed during the day, leaving it down more than 30 percent for the year. The data removed the largest known risk, and the remaining debate moved immediately to the next one: whether a full-approval label, a Q4 filing and a 2027 decision are enough to defend share when the competitor's November decision is six weeks away. The confirmatory number was the one the label was missing. The competitive answer is still pending.
Primary sources
- Vera Therapeutics press release filed with SEC Form 8-K, September 15, 2026, for the ORIGIN 3 final analysis results, including the 76 percent risk reduction, eGFR data and safety figures.
- FDA integrated review for BLA 761486, for the accelerated approval basis and the conditional language on long-term kidney function.
- HCPLive, coverage of the ORIGIN 3 final data, for independent corroboration of the endpoint numbers.
- FiercePharma, coverage of the July 2026 approval, for the competitive framing and the atacicept in-licensing history.