Vera Therapeutics Announces Full Phase 3 Win for Atacicept in Kidney Disease, Prepares FDA Filing by Year’s End

Vera Therapeutics reported positive interim results from the Phase 3 ORIGIN trial of atacicept in IgA nephropathy (IgAN) at ASN Kidney Week 2025 and in The New England Journal of Medicine1 3 4.

Atacicept achieved a 46% reduction in urinary protein-to-creatinine ratio (UPCR) from baseline and a 42% reduction versus placebo at 36 weeks (p<0.0001), meeting the trial's primary endpoint1 6 9.

Secondary outcomes included a 68% reduction in galactose-deficient IgA1 (Gd-IgA1) and resolution of hematuria in 81% of participants with baseline hematuria1.

The safety profile for atacicept was similar to placebo, with lower rates of serious adverse events (0.5% vs 5%) and no deaths reported1.

Vera plans to submit a Biologics License Application (BLA) to the FDA through the Accelerated Approval Program in Q4 2025, targeting a potential U.S. approval and commercial launch in 20261 2.

The ORIGIN 3 trial continues, with blinded two-year renal function (eGFR) outcomes expected in 2027 to assess long-term benefits1.

Atacicept is positioned as a potential first-in-class, disease-modifying therapy for IgAN, addressing a significant unmet need in progressive autoimmune kidney disease2 3.