Positive Phase 3 data from ORIGIN 3 study of atacicept in IgA nephropathy (IgAN) presented at American Society of Nephrology (ASN) Kidney Week and published in the New England Journal of MedicineU.S. Food and Drug Administration (FDA) granted priority review to Biologics License Application (BLA) for atacicept with Prescription Drug User Fee Act (PDUFA) date of July 7, 2026; potential commercial launch of atacicept expected in mid-2026Strong balance sheet bolstered by equity and debt financings in 2025 expe ...

Core Viewpoint - Vera Therapeutics Inc. has received FDA acceptance for the Priority Review of its atacicept Biologics License Application (BLA) aimed at treating immunoglobulin A nephropathy (IgAN), an autoimmune kidney disease that can lead to severe complications [1][3]. Group 1: Product Development - Atacicept is designed as a self-administered subcutaneous injection to be taken once a week, targeting B-cell Activating Factor (BAFF) and A Proliferation-Inducing Ligand (APRIL), which are cytokines involved in the production of autoantibodies related to IgAN and other autoimmune kidney diseases [2]. - The BLA was submitted under the Accelerated Approval Program, with a Prescription Drug User Fee Act (PDUFA) target action date set for July 7, 2026 [3]. Group 2: Clinical Data - The BLA submission is supported by interim analysis data from the ORIGIN 3 trial, which showed a 46% reduction in proteinuria at week 36 for participants treated with atacicept, compared to a statistically significant 42% reduction versus placebo [4]. Group 3: Market Potential - Analysts project that atacicept could tap into a multi-billion-dollar market, with a peak sales forecast of $3 billion by 2037, contingent on further clinical validation [5]. - The competitive landscape includes Novartis A/S's Fabhalta (iptacopan), which has shown significant efficacy in slowing IgAN progression in a Phase 3 study [6]. Group 4: Stock Performance - Following the FDA news, Vera Therapeutics shares increased by 4.49%, reaching $48.61 [7].