On July 7, 2026, the FDA granted accelerated approval to Vera Therapeutics' TRUTAKNA (atacicept-vymj) for treating adult patients with primary IgA nephropathy. As the first dual BAFF and APRIL inhibitor, TRUTAKNA targets the immunological drivers of this progressive kidney disease. In clinical trials, it achieved a 42% reduction in proteinuria compared to placebo. The approval sent Vera's shares up 6.8% as it enters a competitive market alongside treatments from Novartis and Otsuka.
FDA approval of TRUTAKNA
- ▪Following the U.S. Food and Drug Administration's approval of TRUTAKNA on July 7, 2026, Vera Therapeutics' shares rose 6.8% in afternoon trading
- ▪TRUTAKNA is a self-administered injectable treatment with a recommended dose of 150 mg injected subcutaneously once weekly via an autoinjector
- ▪The U.S. Food and Drug Administration granted accelerated approval to Vera Therapeutics' TRUTAKNA (atacicept-vymj) to reduce proteinuria in adults with primary IgA nephropathy
BAFF APRIL targeting mechanism
- ▪TRUTAKNA is the first and only available therapy that binds both B-cell activating factor (BAFF) and A PRoliferation-Inducing Ligand (APRIL)
- ▪By targeting BAFF and APRIL, TRUTAKNA inhibits the two key cytokines acting on B cells that drive the production of disease-causing antibodies in IgA nephropathy
Clinical trial efficacy results
- ▪The ORIGIN 3 trial is continuing to evaluate TRUTAKNA's effect on kidney function, with data now expected in the third quarter of 2026
- ▪In a prespecified interim analysis of the ORIGIN 3 trial, patients treated with TRUTAKNA achieved a 46% reduction in proteinuria from baseline and a 42% reduction compared to placebo at 36 weeks
- ▪In its registrational program, TRUTAKNA was generally well tolerated, with the most common adverse reactions being infections and local administration reactions
IgA nephropathy disease background
- ▪IgA nephropathy, also known as Berger's disease, is a progressive, immune-mediated kidney disease caused by the buildup of immune antibodies in the kidneys
- ▪IgA nephropathy is estimated to affect approximately 160,000 patients in the United States and is a leading cause of chronic kidney disease and kidney failure
Patient treatment experience
- ▪Ben Lager, a 65-year-old Denver musician diagnosed with IgA nephropathy in 2020, joined the Vera Therapeutics clinical trial in 2021 to avoid high-dose steroids
- ▪Ben Lager reported that blood and protein in his urine disappeared within weeks of starting TRUTAKNA treatment, and his energy levels improved
Competitive IgA nephropathy market
- ▪TRUTAKNA enters a competitive IgA nephropathy market that already includes Otsuka's Voyxact, Novartis' Fabhalta, Travere Therapeutics' Filspari, and Calliditas Therapeutics' Tarpeyo
- ▪Vera Therapeutics CEO Marshall Fordyce pushed for an earlier assessment of kidney-function data because high-risk patients cannot afford to wait years while their disease progresses
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