Akebia Therapeutics, Inc.

Overview

Akebia Therapeutics is a fully integrated biopharmaceutical company focused on kidney disease. The company commercializes two products for complications of chronic kidney disease (CKD) and maintains a pipeline of mid- and early-stage programs targeting kidney and non-kidney indications.

Commercial products

Vafseo (vadadustat)

• Oral HIF prolyl hydroxylase inhibitor for anemia due to CKD in adults on dialysis.
• FDA approval: March 2024 for adult patients on dialysis for at least three months.
• U.S. launch: January 2025.
• U.S. market opportunity for adult dialysis anemia: approximately $1 billion.
• International approval: approved for adults in 37 countries; marketed outside the U.S. by partners.
• Commercial reach (as of 2025): contracts with dialysis organizations that care for nearly 100% of U.S. dialysis patients; prescribing access for about 290,000 U.S. dialysis patients; roughly 1,000 prescribers across 24 dialysis organizations have written prescriptions.
• Access and reimbursement: two-year TDAPA reimbursement in the U.S. in addition to the ESRD Bundle; top five U.S. dialysis organizations (DaVita, Fresenius KidneyCare, USRC, Dialysis Clinic, Inc. (DCI), and Innovative Renal Care (IRC)) serve about 82% of dialysis patients.
• Commercial organization: dedicated team of approximately 35 key account managers; ongoing protocol development with dialysis organizations to enable prescribing access.
• Ongoing activities: data generation to support potential clinical benefits versus ESAs; efforts to expand prescribing breadth and depth, including home dialysis populations.
• Product-study timelines: topline data from VOICE expected in 2026; VOCAL post-marketing data expected 2026–2027.
• Strategic update: VALOR trial for non-dialysis CKD patients was canceled in October 2025; the company is evaluating smaller subpopulations for potential pathways forward.

Auryxia (ferric citrate)

• Oral treatment for hyperphosphatemia and iron deficiency anemia in CKD patients (dialysis-dependent and non-dialysis-dependent).
• Part of the portfolio since 2018 and historically contributed meaningful revenue.
• Coverage changes: included in the ESRD Prospective Payment System (PPS) bundle for 2025; two-year TDAPA reimbursement applies to new drugs accompanying the ESRD bundle.
• Intellectual property and competition: loss of exclusivity in March 2025; Teva received tentative FDA approval for an abbreviated application on January 22, 2026; one authorized generic is currently on the market and further generic entries are expected in 2026.
• International: ferric citrate is approved outside the U.S. in select countries through partners.
• Access: broad access supported by contracts with the major dialysis organizations.

Market and access

• Estimated U.S. CKD population: 35.5 million patients (industry data cited in the filing).
• 2022 Medicare costs cited in the filing: approximately $95.7 billion for CKD beneficiaries and $45.3 billion for dialysis patients.
• Dialysis access details summarized under product sections above.

Pipeline and development (selected highlights)

• AKB-097 (anti-C3d–Factor H fusion protein)

  • Asset purchase completed November 2025 from Q32 Bio Inc. and Q32 Bio Operations Inc.
  • Planned Phase 2 open-label basket study in H2 2026 evaluating C3 glomerulopathy (C3G), IgA nephropathy (IgAN), and lupus nephritis (LN).
  • Initial data expected in 2027.

• Praliciguat (sGC stimulator)

  • Licensed from Cyclerion Therapeutics (since June 2021).
  • Phase 2 randomized study in biopsy-confirmed FSGS initiated December 2025 (~60 patients).
  • Prior data in diabetic kidney disease showed reductions in urinary albumin-to-creatinine ratio; preclinical data supported podocyte protection.

• AKB-9090

  • HIF-based candidate focused on cardiac surgery–related acute kidney injury (CS-AKI).
  • Phase 1 in healthy volunteers planned for the first half of 2026.
  • Potential exploration in ARDS and other indications.

• AKB-10108

  • HIF-based program targeting retinopathy of prematurity (ROP) in neonates; currently in preclinical development.

• Strategy

  • Continue to develop the HIF platform and pursue internal discovery and external innovation to expand beyond kidney disease and pursue strategic growth opportunities.

Manufacturing, supply, and operations

• The company uses contract manufacturing organizations (CMOs) for preclinical, clinical, and commercial supply; it does not operate its own manufacturing facilities.
• Vafseo supply: STA Pharmaceutical (Hong Kong) for drug substance and drug product; Patheon Inc. for drug product.
• Distribution and logistics: Cardinal Health, Inc. appointed as exclusive third-party logistics and distribution agent for Auryxia and Vafseo.
• All clinical and commercial supplies are manufactured under cGMPs.
• The company relies on third-party CMOs and distributors, which can limit direct control over capacity and scheduling and may affect timelines.

Financial and strategic considerations

• The company has incurred substantial losses since inception and expects to continue incurring losses. It may require additional financing and could face dilution or other risks if capital is not obtained on favorable terms.
• Factors that may affect the company’s strategic and financial outlook include generic competition for Auryxia, regulatory outcomes for Vafseo (including non-dialysis CKD opportunities), and the performance of ongoing partnerships and manufacturing arrangements.