Vera Therapeutics stock: ORIGIN 3 backs 2026 FDA filing plan

Vera Therapeutics put its lead drug candidate on a clearer regulatory path on October 22, 2026, when it reported positive final efficacy results from the Phase 3 ORIGIN 3 trial of TRUTAKNA in IgA nephropathy. The company said the study met its primary endpoint for proteinuria reduction at 36 weeks and achieved statistical significance across all prespecified endpoints. The results were presented at ASN Kidney Week and published in the New England Journal of Medicine, according to the company release.

Trial data set up next regulatory step

TRUTAKNA also produced statistically significant improvements in estimated glomerular filtration rate, its annualized slope and the risk of composite kidney disease progression events. The drug reduced urine protein-to-creatinine ratio, galactose-deficient IgA1 and hematuria, the company said.

The safety profile was generally comparable with placebo. Adverse events occurred in 75 percent of patients receiving TRUTAKNA and 78 percent of those receiving placebo, while serious adverse events occurred in 7 percent and 15 percent, respectively. Infection rates were similar in the two groups.

FDA filing remains the next catalyst

Vera plans to submit a supplemental biologics license application to the U.S. Food and Drug Administration in the fourth quarter of 2026. The company said potential full approval could follow in 2027. TRUTAKNA currently has accelerated approval to reduce proteinuria in adults with primary IgA nephropathy at risk for disease progression; long-term slowing of kidney-function decline has not yet been established.

The company is scheduled to host its third-quarter 2026 financial results webcast on November 5, 2026, at 4:30 p.m. Eastern time, according to its investor relations site.

Focused kidney biotechnology platform

Vera Therapeutics is a Brisbane, California-based biotechnology company focused on autoimmune diseases, starting with kidney disease. Its flagship product is TRUTAKNA, a once-weekly subcutaneous BAFF and APRIL inhibitor for IgA nephropathy, while the company is also developing programs aimed at additional immune-mediated conditions. Vera is a focused specialist rather than a diversified pharmaceutical group, with its commercial strategy centered on kidney and autoimmune medicine.

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