Corporate events
2TRUTAKNA™ granted accelerated approval by U.S. Food and Drug Administration (FDA) in adult patients with primary IgA nephropathy (IgAN) at risk for disease progression.
Outlook
7Alignment with FDA on earlier ORIGIN 3 final efficacy analysis to support potential full approval for TRUTAKNA in adults with IgAN; results expected in Q3 2026.
Anticipated supplemental Biologics License Application (sBLA) submission to the FDA – expected in Q4 2026.
Management commentary
“The accelerated approval and commercial launch of TRUTAKNA represent transformative milestones for Vera Therapeutics and are the result of of years of hard work and dedication.
We are extremely grateful to the patients, investigators, employees, and collaborators who have contributed to this moment,” said Marshall Fordyce, M.D., Founder and Chief Executive Officer of Vera Therapeutics.
“We are thrilled that TRUTAKNA is available to eligible patients as the first and only therapy to inhibit both BAFF and APRIL in IgAN patients.
We are focused on a successful U.S. launch of TRUTAKNA, and we continue to advance the ORIGIN 3 program in support of a potential full approval.”
“Our team has decades of experience commercializing innovative therapies, successfully launching multiple blockbusters and kidney therapies,” added Matt Skelton, Chief Commercial Officer of Vera Therapeutics.
"Since receiving approval, our team has been promoting TRUTAKNA, and the early reception has been encouraging.
We are laying the groundwork for long-term leadership in helping IgAN patients.
We believe that the efficacy and safety profile of TRUTAKNA and the quality of our people will allow us to effectively serve nephrologists and IgAN patients in their treatment decisions.”
TRUTAKNA positioned to address significant patient need as the first and only BAFF and APRIL inhibitor approved for IgAN .
IgAN is a serious, progressive kidney disease driven by B-cell–mediated immune complex formation.
TRUTAKNA is the first FDA-approved therapy to target both B-cell activating factor (BAFF) and A PRoliferation-Inducing Ligand (APRIL), the key upstream drivers of IgAN pathophysiology.
There are approximately 160,000 diagnosed IgAN patients in the U.S., roughly ~75% of whom are commercially insured.
Strong clinical profile positions TRUTAKNA as a potential foundational therapy in IgAN .
The accelerated approval of TRUTAKNA was based on results from the ORIGIN Phase 3 trial, published in the New England Journal of Medicine in November 2025.
3At 36 weeks, TRUTAKNA demonstrated a 46% reduction from baseline and 42% reduction versus placebo in proteinuria, with consistent benefit across all prespecified subgroups.
Results
4TRUTAKNA-treated patients also showed a 68% reduction in galactose-deficient IgA1 (Gd-IgA1) and resolution of hematuria in 81% of patients with hematuria at baseline.
TRUTAKNA was generally well tolerated, with no serious, severe, or opportunistic infections and no cases of hypogammaglobulinemia observed.
In addition, there were no clinically significant effects of anti-drug antibodies on the pharmacokinetics, pharmacodynamics, safety, or efficacy of TRUTAKNA over the treatment period.
TRUTAKNA is a once-weekly, at-home autoinjector, a desirable presentation for patients with proven success in other diseases.
Corporate events
Experienced team executing on U.S. specialty launch .
Vera Therapeutics has assembled an experienced cross-functional organization across sales, marketing, market access, patient support, and medical affairs with decades of experience in rare disease and kidney therapies.
Eligible commercially insured patients may pay as little as $0 out of pocket through the TRUTAKNA TRU SUPPORT™ program.
1Received FDA accelerated approval for TRUTAKNA to reduce proteinuria in adult patients with primary IgAN at risk for disease progression
U.S. commercial launch of TRUTAKNA, the first and only available therapy that binds both BAFF and APRIL, is underway
Aligned with the FDA on an earlier ORIGIN 3 final efficacy analysis to support potential full approval of TRUTAKNA in adults with IgAN
Announced the appointment of Nancy Boman, M.D., Ph.D. as Chief Regulatory Officer of Vera Therapeutics, succeeding William Turner, effective upon his retirement and transition to the role of Strategic Advisor in the third quarter of 2026
TRUTAKNA extended dose range finding study enrollment complete
Outlook
Anticipated Upcoming Milestones
Final efficacy analysis from the ORIGIN 3 trial expected in Q3 2026
Anticipated sBLA submission to the FDA expected in Q4 2026
Additional PIONEER clinical results expected in Q4 2026
Potential full approval of TRUTAKNA in IgAN expected in 2027
Results
Financial Results for the Quarter Ended June 30, 2026
5For the quarter ended June 30, 2026, Vera Therapeutics reported a net loss of $109.5 million, or a net loss per share of $1.52, compared to a net loss of $76.5 million, or a net loss per share of $1.20, for the quarter ended June 30, 2025.
6During the six months ended June 30, 2026, net cash used in operating activities was $206.8 million, compared to $109.2 million for the quarter ended June 30, 2025.
8Vera Therapeutics reported $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 the satisfaction of certain conditions.
Management commentary
Vera Therapeutics
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