Atacicept is a once weekly injection that blocks BAFF and APRIL, two immune signals driving IgA nephropathy, a rare autoimmune kidney disease; full approval now hinges on whether it slows kidney decline by Q3 2026.
The FDA approved Vera Therapeutics' atacicept on July 7, 2026 for adults with IgA nephropathy, an autoimmune disease that affects the kidneys' filtering units and afflicts roughly 130,000 Americans. The agency cleared it through the accelerated approval pathway, with full conversion now riding on a two-year eGFR readout expected in the third quarter of 2026.
Atacicept is the first dual inhibitor of BAFF and APRIL, two immune signals that drive the B-cell cascade behind IgA nephropathy. Patients self-inject 150 milligrams once a week via an autoinjector.
The data underpinning the approval came from the 431-patient ORIGIN 3 Phase 3 trial. At 36 weeks, atacicept cut 24-hour urine protein by 46% from baseline, a 42% relative reduction versus placebo (p<0.0001). The drug also drove the disease-driver galactose-deficient IgA1 antibody down 68% and resolved hematuria in 81% of treated patients, compared with 20.7% on placebo, according to results published in the New England Journal of Medicine in February 2026 and presented as a late-breaker at American Society of Nephrology Kidney Week 2025.
Serious adverse events ran lower on atacicept (0.5%) than on placebo (5%), with no deaths and no broad immunosuppression signal emerging, per Vera's November 2025 readout. That profile, alongside the proteinuria, Gd-IgA1, and hematuria improvements, supported the FDA's January 2026 Priority Review acceptance and the drug's Breakthrough Therapy Designation.
Accelerated approval means proteinuria, Gd-IgA1, and hematuria are credible surrogates for kidney risk in IgA nephropathy but not full substitutes for a direct kidney-function benefit. ORIGIN 3 continues blinded to its eGFR endpoint, with the two-year readout expected before the end of September 2026.
The existing IgA nephropathy armamentarium includes sparsentan (Filspari, an endothelin receptor antagonist) and delayed-release budesonide (Tarpeyo, a targeted steroid). Atacicept enters as the first B-cell modulator to show concurrent proteinuria, hematuria, and Gd-IgA1 improvements in a Phase 3 IgA nephropathy trial.
Vera shares ran up about 6% on July 6 ahead of the decision. Founder and chief executive Marshall Fordyce, M.D. told STAT+: "We're extremely excited to bring Trutakna to patients." Per STAT+, the brand name is Trutakna; Vera's approval-day release and the FDA prescribing label, expected shortly, will independently confirm it.
The Q3 2026 eGFR readout will decide whether atacicept slows kidney-function decline, not just proteinuria. A positive slope locks in a permanent label. A negative slope resets the calculus, and the FDA's accelerated-approval machinery allows label revision or withdrawal on surrogate-only evidence.