Akebia Therapeutics Announces Multiple Positive Business Updates

Core Insights - Akebia Therapeutics has secured commercial supply contracts for Vafseo® (vadadustat), achieving nearly 100% coverage of dialysis patients in the U.S. [2][7] - Vafseo tablets are now shipping in the U.S. for adult patients with anemia due to chronic kidney disease (CKD) on dialysis for at least three months [2][4] - The company plans to initiate a Phase 3 trial in mid-2025 to potentially expand Vafseo's label to include treatment for late-stage non-dialysis CKD patients [3][4] Commercial Developments - Vafseo began shipping to dialysis centers on January 9, 2025, with broad access secured through agreements with dialysis organizations [7] - Market research indicates that 99% of nephrologists would consider prescribing Vafseo, with 75% intending to do so within six months of availability [7] - Akebia has engaged with the FDA regarding a Phase 3 cardiovascular outcome study for late-stage CKD anemia patients not on dialysis, expected to start in mid-2025 [3][7] Financial Outlook - The CEO of Akebia believes the company is entering a transformational year with the U.S. market availability of Vafseo, which could become a new standard of care for CKD patients [4] - The potential market opportunity for expanding Vafseo's label into the non-dialysis population is estimated to be multiple billion dollars in the U.S. [4] - Akebia expects its existing cash resources and cash from operations to be sufficient to fund its current operating plan for at least two years [7][8]