Vera Therapeutics announced that the U.S. Food and Drug Administration has accepted its biologics license application for atacicept and granted the drug Priority Review status. The acceptance places atacicept on a faster regulatory track with a target action date of July 7 2026, underscoring the FDA’s recognition of the unmet medical need in immunoglobulin A nephropathy (IgAN) and the strength of the company’s late‑stage data.
Atacicept is a dual BAFF/APRIL inhibitor that was evaluated in the Phase 3 ORIGIN 3 trial. A prespecified interim analysis showed a 46 % reduction in proteinuria from baseline and a 42 % reduction versus placebo (p < 0.0001) at week 36. The data were presented at ASN Kidney Week and published in the New England Journal of Medicine on November 6 2025, providing robust evidence of clinical benefit.
If approved, atacicept would be offered as a once‑weekly subcutaneous autoinjector for at‑home use, offering a convenient dosing schedule that could improve adherence. IgAN affects an estimated 1 million people worldwide, with at least 50 % of patients progressing to end‑stage kidney disease. The global IgAN treatment market is projected to reach $15 billion at peak, creating a sizable opportunity for a first‑in‑class therapy.
The IgAN landscape now includes Fabhalta (iptacopan), approved under accelerated approval in August 2024, and sibeprenlimab (Voyxact), approved in November 2025. Atacicept would be the first B‑cell modulator that simultaneously targets BAFF and APRIL, potentially offering a distinct mechanism of action and positioning Vera as a best‑in‑class candidate in a crowded market.
Chief Executive Officer Marshall Fordyce said the Priority Review designation validates the company’s scientific strategy and the potential of atacicept to transform care for IgAN patients. He emphasized that the FDA’s decision reflects the drug’s meaningful disease‑modifying benefits and the unmet need in this patient population.
Vera Therapeutics reported a cash balance of $497.4 million as of September 30 2025, with access to an additional $425 million in non‑dilutive capital. The funding position is expected to support operations through the regulatory review and potential launch, providing a runway for commercialization activities and further development.
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