Core Insights - Akebia Therapeutics is positioned to enhance the prescribing of Vafseo, targeting approximately 275,000 patients by 2026, with ongoing clinical trials and pipeline developments in rare kidney diseases [1][2] Vafseo Commercial Business - The company anticipates increased demand for Vafseo as existing customers accelerate adoption and new customers implement Vafseo protocols [2] - Vafseo is being positioned as the standard of care for treating anemia due to chronic kidney disease (CKD) in dialysis patients, supported by ongoing clinical data [2] - The company expects Q4 2025 net product revenue for Vafseo to be between $5 million and $6 million, with a projected revenue growth resuming in Q1 2026 [5] Clinical Trials and Pipeline Developments - The first patient has been dosed in the Phase 2 clinical trial for Praliciguat, targeting focal segmental glomerulosclerosis (FSGS) [1] - The AKB-097 Phase 2 rare kidney disease basket trial is set to begin in the second half of 2026, with initial data expected in 2027 [1][12] - Enrollment in the VOICE trial, a Phase IV study with over 2,100 patients, has been completed, with topline results expected in early 2027 [5] Performance Metrics - The total number of prescribers for Vafseo increased by 8% in Q4 2025, reaching approximately 785 [5] - At least 25% of new patients in Q4 2025 came from dialysis organizations other than U.S. Renal Care, up from less than 10% in Q3 [5] - The underlying patient dosing demand for Vafseo in Q4 2025 was estimated between $10.5 million and $11.5 million [5] Rare Kidney Disease Pipeline - AKB-9090, a HIF-PH inhibitor, is entering Phase 1 for acute kidney injury associated with cardiac surgery in the first half of 2026 [7] - The company plans to evaluate IgA Nephropathy, Lupus Nephritis, and C3 Glomerulopathy as part of the AKB-097 study [12]

Core Insights - Akebia Therapeutics Inc. has officially established a rare kidney disease pipeline, focusing on two main product candidates: AKB-097 and praliciguat [1][3] - The company aims to position Vafseo as the standard treatment for anemia in dialysis patients while simultaneously developing a robust pipeline for rare kidney conditions [1] Product Details - Vafseo is an oral treatment for anemia due to chronic kidney disease in adults on dialysis for at least three months, approved in 37 countries, and stimulates endogenous erythropoietin production [2] - AKB-097, previously known as ADX-097, is a humanized anti-C3d monoclonal antibody fusion protein designed to target complement activation at the organ level, potentially reducing infection risks and dosing frequency [3] Financial Transactions - Akebia entered into an Asset Purchase Agreement with Q32 Bio Inc. to acquire global rights to AKB-097, paying an upfront fee of $7 million, with an additional $3 million due six months post-closing [3]