Vera Therapeutics Submits BLA for Atacicept, Reports Increased Operating Losses

**Vera Therapeutics Submits BLA for Atacicept, Reports Increased Operating Losses**

Vera Therapeutics, Inc., a late clinical-stage biotechnology company, announced the submission of a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) in November 2025 for atacicept, a treatment for immunoglobulin A nephropathy (IgAN). The FDA granted priority review to the application in January 2026, setting a Prescription Drug User Fee Act (PDUFA) target action date of July 7, 2026. Atacicept, if approved, would be the first B-cell modulator inhibiting both BAFF and APRIL for IgAN, offering patients an autoinjector for at-home self-administration. The company is also conducting the ORIGIN EXTEND trial, a Phase 2 extension study, and the PIONEER trial, a Phase 2 basket trial evaluating atacicept in an expanded IgAN cohort and other autoimmune-mediated glomerular diseases.

The company's financial results for the year ended December 31, 2025, revealed a net loss of $299.6 million, compared to a net loss of $152.1 million for the year ended December 31, 2024. This increase in net loss was primarily driven by a significant rise in operating expenses, which totaled $315.5 million in 2025, up from $167.2 million in the previous year. Research and development expenses increased to $215.3 million from $126.2 million, while general and administrative expenses rose to $100.2 million from $41.0 million. The company has an accumulated deficit of $760.9 million as of December 31, 2025.

Key operational developments included the acquisition of worldwide rights to VT-109, a novel BAFF/APRIL inhibitor, in January 2025. The company also reported that the Phase 3 ORIGIN 3 trial of atacicept met its primary efficacy endpoint. As of December 31, 2025, Vera Therapeutics had 249 full-time employees. The company's cash, cash equivalents, and marketable securities totaled $714.6 million as of December 31, 2025, compared to $640.9 million as of December 31, 2024.

Looking ahead, Vera Therapeutics anticipates that its existing cash, cash equivalents, and marketable securities will be sufficient to fund its planned operations and capital expenditure requirements beyond the next 12 months. The company expects research and development expenses to increase as it continues to pursue regulatory approval for atacicept and advance its other pipeline programs. The company also expects general and administrative expenses to increase as it prepares for the potential commercial launch of atacicept. Vera Therapeutics may seek additional funding through public or private equity offerings, debt financings, collaborations, and licensing arrangements.