Vera Therapeutics Secures FDA Priority Review and $800M Financing after Positive Phase 3 Data
Vera Therapeutics reported positive ORIGIN Phase 3 data for atacicept in IgAN and secured FDA priority review with a PDUFA date of July 7, 2026. Equity and debt financings provided $800 million and cash, cash equivalents and securities totaled $714.6 million to fund operations beyond approval and U.S. launch.
1. Positive Phase 3 Data and FDA Review
Vera Therapeutics presented positive primary endpoint results from the ORIGIN Phase 3 trial of atacicept in IgA nephropathy, demonstrating clinically meaningful reductions in proteinuria, Gd-IgA1 and hematuria. The FDA granted priority review to the atacicept BLA with a PDUFA target action date of July 7, 2026, and Vera is preparing for a potential mid-2026 U.S. launch.
2. Financing and Balance Sheet Strength
During 2025, Vera completed equity and debt financings resulting in potential gross proceeds of $800 million. As of December 31, 2025, the company held $714.6 million in cash, cash equivalents and marketable securities, which it expects to fund operations through potential approval and U.S. commercialization of atacicept.
3. 2025 Financial Performance
For the year ended December 31, 2025, Vera reported a net loss of $299.6 million, or $4.66 per diluted share, compared to a net loss of $152.1 million the prior year. Net cash used in operating activities was $241.1 million versus $134.7 million in 2024, reflecting increased investment in the atacicept program.
4. Anticipated Upcoming Milestones
Key upcoming catalysts include the PDUFA decision on July 7, 2026, a planned mid-2026 U.S. commercial launch if approved, initial Phase 2 PIONEER data in 1H 2026, and completion of two-year eGFR data from the ORIGIN 3 study in 2027.