Business
Vera Therapeutics Provides Business Update and Reports Second Quarter 2024 Financial Results
Received FDA Breakthrough Therapy Designation for atacicept in IgA Nephropathy (IgAN)Presented data from Phase 2b ORIGIN study at ERA24 Congress showing
About this update from Vera Therapeutics, Inc.
[{"type":"text","content":"Received FDA Breakthrough Therapy Designation for atacicept in IgA Nephropathy (IgAN)Presented data from Phase 2b ORIGIN study at ERA24 Congress showing atacicept stabilized kidney function through 72 weeks and led to rapid reductions in hematuriaTopline 96-week data from Phase 2b ORIGIN study expected in Q4 2024On track to complete enrollment in pivotal Phase 3 ORIGIN 3 trial for primary endpoint in Q3 2024; topline data expected in Q2 2025 BRISBANE, Calif., Aug. 08, 2024 (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 second quarter ended June 30, 2024. “We continue to strengthen the data package for atacicept, including our “Best Ranked Abstract”-winning presentation of Phase 2b data from the ORIGIN trial at ERA24 that shows atacicept stabilized kidney function through 72 weeks and led to rapid reductions in hematuria. These data have generated broad excitement about the potential for atacicept to advance the treatment of IgAN and led to the FDA granting Breakthrough Therapy Designation for atacicept in the treatment of IgAN,” said Marshall Fordyce, M.D., Founder and CEO of Vera Therapeutics. “We look forward to presenting the long-term 96-week clinical data from our Phase 2b ORIGIN trial in the fourth quarter of 2024. In addition, we are on track to complete enrollment in our pivotal ORIGIN 3 Phase 3 trial in the third quarter of 2024, and expect to present topline data from this trial in Q2 2025. We expect these data to support our submission for regulatory approval, which if approved, given the anticipated timeline, would position atacicept as one of the first B-cell modulators to be approved in IgAN.” Second Quarter and Recent Business Highlights Received U.S. Food and Drug Administration (FDA) Breakthrough Therapy Designation for atacicept in the treatment of IgANPresented two oral presentations at the 61st European Renal Association Congress (ERA24), including Best-Ranked Abstract, on the Phase 2b ORIGIN trial of atacicept in immunoglobulin A nephropathy (IgAN) showing atacicept stabilized kidney function through 72 weeks and led to rapid reductions in hematuriaAppointed industry v...