Akebia Therapeutics (NASDAQ: AKBA) is making waves in the biotech sector, with its stock soaring approximately 26% following the release of its fourth-quarter and full-year 2024 financial results. The surge comes as the company reports strong early performance for its newly launched anemia treatment, Vafseo® (vadadustat), in the U.S. dialysis market.

Akebia officially launched Vafseo in the U.S. on January 9, 2025, marking a key milestone for the company. Early indicators suggest strong market uptake:

• First-quarter 2025 net product revenue expectations: Approximately $10-$11 M
• Over 500 prescribers have written prescriptions, averaging around 8 per provider​.
• Three of the top four dialysis organizations in the U.S. have already placed orders​.

Akebia’s CEO has emphasized that this is the first time a drug with Transitional Drug Add-on Payment Adjustment (TDAPA) reimbursement has launched with commercial supply agreements covering nearly 100% of dialysis patients in the U.S.

While revenue took a slight dip compared to 2023, Akebia remains optimistic about its future growth.

• Total 2024 revenue of $160.2 M, down from $194.6 M in 2023, primarily due to declining sales of its older anemia drug, Auryxia®​.
• Akebia reported $51.9 M in cash and cash equivalents as of December 31, 2024​.
• The company expects its cash resources and operational cash flow to fund operations for at least two years​.

Akebia is positioning Vafseo for broader market adoption beyond dialysis patients. The company is preparing to launch a Phase 3 VALOR study in the second half of 2025 to explore Vafseo’s efficacy in treating non-dialysis chronic kidney disease (CKD) patients​. Additionally, Akebia’s partner Medice has launched Vafseo in the United Kingdom, where it has been recommended for use by the U.K. National Institute for Health and Care Excellence (NICE)​.

John P. Butler, Chief Executive Officer of Akebia said: We are also excited about our potential to expand the Vafseo label to the non-dialysis CKD population, and plan to take advantage of the opportunity to meet with the U.S. Food and Drug Administration to discuss the Phase 3 VALOR study protocol. We believe taking the time for this meeting can help drive our efforts to bring a new product to market to treat this underserved patient population. We expect to initiate the VALOR study in the second half of this year.”

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