Vera Therapeutics announced that its ORIGIN Phase 3 study of atacicept in adults with IgA nephropathy met its primary endpoint, showing a 42 % reduction in proteinuria versus placebo (p < 0.0001) and a 46 % drop from baseline. Secondary endpoints were also met, with a 68 % decline in galactose‑deficient IgA1 and hematuria resolution in 81 % of participants.
The trial enrolled 431 patients who were randomized 1:1 to receive 150 mg of atacicept subcutaneously once weekly or placebo. Proteinuria was measured at 36 weeks, and the study remains blinded for a two‑year eGFR assessment expected in 2027. The design mirrors the earlier Phase 2b ORIGIN study, which reported a 31 % reduction in urine protein‑creatinine ratio from baseline versus 8 % with placebo at week 24, underscoring a consistent dose‑response trend.
Safety data were favorable. The incidence of serious adverse events was lower in the atacicept group (1 event, 0.5 %) compared with 11 events (5 %) in the placebo arm, and no deaths were reported. The overall safety profile was comparable to placebo, reinforcing the tolerability of the dual BAFF/APRIL inhibition mechanism.
The data were presented during the opening plenary of the American Society of Nephrology Kidney Week 2025 and were simultaneously published in the New England Journal of Medicine, providing peer‑reviewed validation of the findings. The publication in a high‑impact journal signals robust scientific rigor and enhances the credibility of the results.
Regulatory implications are significant. Vera plans to file a Biologics License Application for accelerated approval in the fourth quarter of 2025, with a potential U.S. commercial launch in 2026. If approved, atacicept would become the first dual BAFF/APRIL inhibitor for IgA nephropathy, offering a novel therapeutic option in a disease with substantial unmet need.
Financially, Vera reported a Q3 2025 net loss of $80.3 million, a widening loss compared with $46.6 million in Q3 2024, reflecting continued investment in late‑stage trials and commercialization preparation. The company’s diluted earnings per share were $‑1.26, slightly below the consensus estimate of $‑1.16. Revenue remained at $0.0 million, consistent with its clinical‑stage status. Cash and cash equivalents stood at $497.4 million as of September 30 2025, providing a runway to support the upcoming regulatory milestones.
CEO Marshall Fordyce expressed enthusiasm about the data, noting that the results confirm atacicept’s clinical benefit and support the company’s accelerated approval strategy. He emphasized that the company remains on track to submit the BLA in the fourth quarter of 2025 and that the data set a strong foundation for a 2026 launch.
The positive Phase 3 data reinforce Vera’s position as a leader in the emerging IgA nephropathy therapeutic space. The robust efficacy, favorable safety, and strong financial backing position the company to capitalize on a first‑to‑market opportunity, while the widening loss and cash burn underscore the need for continued investment until commercialization begins.
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