Business
Vera Therapeutics Provides Business Update and Reports First Quarter 2025 Financial Results
On track to announce the primary endpoint results from the atacicept pivotal Phase 3 ORIGIN trial in IgA Nephropathy (IgAN) in 2Q 2025; planning for Biologics
About this update from Vera Therapeutics, Inc.
[{"type":"text","content":"On track to announce the primary endpoint results from the atacicept pivotal Phase 3 ORIGIN trial in IgA Nephropathy (IgAN) in 2Q 2025; planning for Biologics License Application (BLA) submission for atacicept accelerated approval to the U.S. FDA in 4Q 2025Expanded atacicept development program across multiple autoimmune kidney diseases is underway BRISBANE, Calif., May 06, 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 first quarter ended March 31, 2025. “We are rapidly approaching a significant Vera milestone with the upcoming primary endpoint results from the pivotal atacicept ORIGIN 3 trial, and if successful, we expect this to enable a BLA submission to the FDA in the second half of this year, which may allow approval and commercial launch in 2026. If approved, we believe that atacicept has the potential to advance the standard of care in IgA nephropathy,” said Marshall Fordyce, M.D., Founder and CEO of Vera Therapeutics. “The Vera team is well-positioned to build on the success of the lead atacicept development program in IgAN, with the expansion into additional potential indications in other autoimmune kidney diseases and beyond.” First Quarter 2025 and Recent Business Highlights Completed full enrollment in the pivotal ORIGIN Phase 3 trial of atacicept in IgANEnrolling participants in the ORIGIN EXTEND study, which provides participants in the ORIGIN Phase 2b or Phase 3 trials with extended access to atacicept, and captures longer-term safety and efficacy dataAcquired exclusive development and commercialization rights to VT-109, a novel, next generation fusion protein targeting BAFF and APRIL, with wide therapeutic potential across the spectrum of B cell mediated diseasesIntroduced an expanded development program for atacicept across multiple autoimmune kidney diseases, including primary membranous nephropathy (PMN), focal segmental glomerulosclerosis (FSGS), and minimal change disease (MCD) Major Upcoming Milestones Anticipated announcement of the primary endpoint results from the pivotal ORIGIN 3 trial in 2Q 2025Plan to submit a Biologics License Application (BLA) for atacic...