Vera Therapeutics, Inc. filed a Form 8-K with the SEC on September 15, 2026, disclosing that TRUTAKNA (atacicept-vymj) met all prespecified endpoints in the final efficacy analysis of the ORIGIN 3 trial in adults with primary IgA nephropathy at risk for disease progression.

Key Highlights

  • All prespecified endpoints met: TRUTAKNA met all prespecified endpoints of the final efficacy analysis of the ORIGIN 3 trial, according to the filing.
  • eGFR change at 52 weeks: Mean eGFR change from baseline at 52 weeks was -0.1 mL/min/1.73m2 for TRUTAKNA versus -5.7 mL/min/1.73m2 for placebo, a treatment effect of 5.6 (95% CI 3.7, 7.5), with p-value less than 0.0001.
  • Annualized eGFR slope through 104 weeks: -0.6 mL/min/1.73m2/year for TRUTAKNA versus -5.6 mL/min/1.73m2/year for placebo, treatment effect 5.0 (95% CI 3.6, 6.5), p-value less than 0.0001.
  • Composite kidney disease progression: 11 events in the TRUTAKNA group versus 38 in the placebo group, with a hazard ratio of 0.24 (95% CI 0.12, 0.48), representing a 76% risk reduction, p-value less than 0.0001.
  • Serious outcomes: Zero patients in the TRUTAKNA group experienced dialysis for 30 or more days, transplant, or death through 104 weeks, compared with 8 in the placebo group.
  • Safety profile: TRUTAKNA was reported as "well tolerated with a favorable safety profile generally comparable to placebo," with no opportunistic infections or clinically relevant hypogammaglobulinemia observed.

ORIGIN 3 Final Efficacy Analysis: Data From 428 Patients

According to the filing, the final analysis set included 428 patients enrolled in the ORIGIN 3 trial. The trial evaluated TRUTAKNA (atacicept-vymj) in adults with primary IgA nephropathy at risk for disease progression. The company disclosed that the eGFR results "align with the KDIGO treatment goal to reduce the rate of kidney function decline to the physiologic rate (<1 mL/min/1.73m2/year)." The annualized eGFR slope for the TRUTAKNA group through 104 weeks was -0.6 mL/min/1.73m2/year, compared with -5.6 mL/min/1.73m2/year for placebo.

Beyond eGFR endpoints, the filing stated that TRUTAKNA also achieved statistically significant reductions in the hierarchically tested endpoints of proteinuria, galactose-deficient IgA1, and hematuria. On the composite kidney disease progression outcome through 104 weeks, the TRUTAKNA group recorded 11 events versus 38 in the placebo group, yielding a hazard ratio of 0.24 (95% CI 0.12, 0.48) and a stated 76% risk reduction, with a p-value of less than 0.0001.

The filing reported that rates of overall adverse events and infections or infestations were similar between the TRUTAKNA and placebo groups, and described the safety profile as "consistent with previous results from the ORIGIN program." The disclosures were made under Item 7.01 (Regulation FD) and Item 8.01 (Other Events) of the Current Report filed by NASDAQ:VERA. The company noted that forward-looking statements are addressed in Exhibit 99.2 and are subject to the cautionary language contained therein.

What Was Disclosed

Vera Therapeutics disclosed final efficacy and safety results from the 428-patient ORIGIN 3 trial of TRUTAKNA in IgA nephropathy, reporting that the drug met all prespecified endpoints with statistically significant improvements in eGFR, composite disease progression, and proteinuria versus placebo.