Vera Therapeutics reports Q2 2026 results after TRUTAKNA accelerated approval

Vera Therapeutics said on August 10, 2026 that TRUTAKNA was granted accelerated approval by the FDA in adult patients with primary IgA nephropathy (IgAN) at risk for disease progression.¹ The company also said it has aligned with the FDA on an earlier ORIGIN 3 final efficacy analysis to support potential full approval for TRUTAKNA in adults with IgAN, with results expected in the third quarter of 2026.¹ Vera said it anticipates a supplemental Biologics License Application submission to the FDA in the fourth quarter of 2026.¹

On the clinical data behind the approval, Vera said the accelerated approval was based on results from the ORIGIN Phase 3 trial, published in the New England Journal of Medicine in November 2025, showing at 36 weeks a 46% reduction from baseline and 42% reduction versus placebo in proteinuria, with consistent benefit across all prespecified subgroups.¹ The release also noted a 68% reduction in galactose-deficient IgA1 and resolution of hematuria in 81% of patients with hematuria at baseline.¹

The prescribing information in the same release states that infections were reported in 32% of TRUTAKNA patients compared with 28% of placebo patients in clinical trials,¹ and that the most common adverse reactions (≥5%) were infections (32% vs 28%) and local administration reactions (30% vs 5%).¹ Separately, the launch-update section of the release described TRUTAKNA as having shown no serious, severe, or opportunistic infections and no cases of hypogammaglobulinemia in the trial, and stated the drug was generally well tolerated.¹ The two sections of the release differ in how infection-related findings are characterized.

Vera also disclosed that enrollment is complete in the TRUTAKNA extended dose range finding study, and that Nancy Boman was appointed Chief Regulatory Officer, succeeding William Turner, who is set to transition to a Strategic Advisor role in the third quarter of 2026.¹ Additional PIONEER clinical results are expected in the fourth quarter of 2026, and potential full approval of TRUTAKNA in IgAN is expected in 2027, per the release's milestone list.

On financials, Vera reported a net loss of $109.5 million, or $1.52 per share, for the quarter ended June 30, 2026, compared with a net loss of $76.5 million, or $1.20 per share, a year earlier.¹ The company said it held $499.2 million in cash, cash equivalents, and marketable securities as of June 30, 2026, plus up to $425 million available under its debt facility, subject to certain conditions.¹