Business
Vera Therapeutics Provides Business Update and Reports Fourth Quarter and Full Year 2024 Financial Results
On track to announce the primary endpoint result from the atacicept pivotal Phase 3 ORIGIN trial in IgA Nephropathy (IgAN) in 2Q 2025; BLA submission to the
About this update from Vera Therapeutics, Inc.
[{"type":"text","content":"On track to announce the primary endpoint result from the atacicept pivotal Phase 3 ORIGIN trial in IgA Nephropathy (IgAN) in 2Q 2025; BLA submission to the U.S. FDA for accelerated approval planned in 2H 2025Expanded atacicept clinical development program in multiple autoimmune kidney diseases proceeding in 2025Strengthened balance sheet to support clinical pipeline development, planned FDA submission, and potential 2026 commercial launch of atacicept for the treatment of IgAN BRISBANE, Calif., Feb. 26, 2025 (GLOBE NEWSWIRE) -- Vera Therapeutics, Inc. (Nasdaq: VERA), a late clinical-stage biotechnology company focused on developing and commercializing transformative treatments for patients with serious immunological diseases, today reported its business highlights and financial results for the fourth quarter and full year ended December 31, 2024. “Vera is poised to change the standard of care in autoimmune diseases with atacicept, our investigational therapy, beginning with IgA nephropathy. We are on track to announce the primary endpoint result of the ORIGIN Phase 3 study in the second quarter of this year. We look forward to submitting a Biologics License Application (BLA) for this potential best-in-class therapy in the second half of this year. We are grateful to the study investigators and participants for their ongoing and enthusiastic participation in this program,” said Marshall Fordyce, M.D., Founder and CEO of Vera Therapeutics. “In addition, over the past year we have made progress advancing our broader development pipeline, including additional potential indications for atacicept.” Fiscal 2024 and Recent Business Highlights Received FDA Breakthrough Therapy Designation for atacicept in IgANPresented positive data showing eGFR stabilization over 96 weeks in the ORIGIN Phase 2b clinical trial of atacicept in IgAN in a late-breaking oral presentation at the American Society of Nephrology Kidney Week 2024, and in a simultaneous peer-reviewed publication in the Journal of the American Society of NephrologyInitiated the ORIGIN Extend study, providing ORIGIN 2b/3 participants with extended access to atacicept and capturing longer-term safety and efficacy dataAnnounced an expanded development pipeline for atacicept across multiple autoimmune kidney diseases, including primary membranous nephropathy (PMN), focal segmental glo...