Core Insights - Akebia Therapeutics reported a significant increase in net product revenues for Vafseo, reaching $14.3 million in Q3 2025, contributing to total net product revenues of $56.8 million for the quarter [1][12] - The company aims to make Vafseo the standard of care for treating anemia in dialysis patients, with expectations to quadruple prescribing access by year-end [2][4] - A recent post-hoc analysis presented at ASN Kidney Week indicated that patients receiving vadadustat had statistically more favorable outcomes in terms of all-cause mortality and hospitalization compared to those receiving erythropoiesis-stimulating agents (ESAs) [1][6] Financial Results - Total revenues increased to $58.8 million in Q3 2025 from $37.4 million in Q3 2024, driven by Vafseo and Auryxia sales [12] - Auryxia net product revenues were $42.5 million in Q3 2025, up from $35.6 million in Q3 2024, despite the loss of exclusivity in March 2025 [12] - The company reported a net income of $0.5 million in Q3 2025, a significant improvement from a net loss of $20.0 million in Q3 2024 [12][32] Operational Highlights - An operational pilot of Vafseo at DaVita is expected to complete in Q4 2025, with access anticipated for 275,000 patients by year-end [1][6] - The number of prescribers for Vafseo reached approximately 725 in Q3 2025, with an average of 12.7 prescriptions written per prescriber [6] - The average dose of refills for Vafseo increased by 5% over Q2 2025, indicating growing acceptance among healthcare providers [6] Regulatory Update - Akebia did not achieve alignment with the FDA on its proposed path for a Phase 3 clinical trial in non-dialysis patients and does not plan to initiate the VALOR clinical trial [4][29]
Akebia Therapeutics Reports Third Quarter 2025 Financial Results and Recent Business Highlights