Akebia reports mixed results for anemia drug in global study

CAMBRIDGE, Mass. - Akebia Therapeutics Inc. (NASDAQ:AKBA), a biopharmaceutical firm focused on kidney disease treatments with a market capitalization of approximately $898 million, announced today that the Journal of the American Society of Nephrology (JASN) has published analyses from its global phase 3 clinical trials of vadadustat, comparing it with darbepoetin alfa for treating anemia in chronic kidney disease (CKD) patients. The company’s stock has shown remarkable momentum, delivering a 203% return over the past year. According to InvestingPro analysis, the stock is currently trading above its Fair Value, with 13 additional ProTips available to subscribers regarding the company’s financial health and market position.

The studies, which included both dialysis-dependent (DD-CKD) and non-dialysis-dependent (NDD-CKD) patients, aimed to assess the safety and efficacy of vadadustat. While results for the U.S. subgroup showed similar outcomes between vadadustat and darbepoetin alfa for DD-CKD patients, the NDD-CKD subgroup exhibited a higher risk of major adverse cardiovascular events (MACE) with vadadustat compared to darbepoetin alfa outside the United States. The company maintains a strong financial position with a current ratio of 2.23, indicating sufficient liquidity to meet short-term obligations, while operating with a moderate debt-to-capital ratio of 0.20.

Akebia’s vadadustat, marketed as Vafseo®, was approved by the U.S. Food and Drug Administration in March 2024 for anemia due to CKD in adults on dialysis for a minimum of three months and has been available in the U.S. since January 2025. The company emphasizes the importance of these geographic-specific analyses for U.S. physicians when making treatment decisions for CKD-related anemia.

Dr. Steven K. Burke, Senior Vice President, Research & Development, and Chief Medical Officer of Akebia, highlighted that the regional differences in patient characteristics and clinical practices can influence outcomes in global trials.

Vafseo is an oral hypoxia-inducible factor prolyl hydroxylase inhibitor that stimulates endogenous erythropoietin production, thereby increasing hemoglobin and red blood cell production. It is currently approved for use in 37 countries.

The press release also includes safety warnings for Vafseo, noting an increased risk of thrombotic vascular events and advising the use of the lowest effective dose. Other risks associated with the treatment include hypertension, hepatotoxicity, seizures, and gastrointestinal erosion.

The company’s forward-looking statements reflect its expectations regarding the importance of vadadustat clinical data and its potential to further physicians’ understanding of Vafseo. While analysts maintain a strong buy consensus with price targets ranging from $6 to $10 per share, these statements are subject to various risks and uncertainties. For comprehensive analysis of Akebia’s financial health, growth prospects, and detailed valuation metrics, access the full InvestingPro Research Report, part of the extensive coverage available for 1,400+ US equities.

This article is based on a press release statement from Akebia Therapeutics.

In other recent news, Akebia Therapeutics reported its Q1 2025 earnings, exceeding expectations with an earnings per share (EPS) of $0.03, compared to a forecast of -$0.05. The company’s revenues rose to $57.3 million, surpassing the projected $44.38 million. This performance marks a significant improvement from the previous year’s net loss, as Akebia achieved a net income of $6.1 million. The financial results were driven by strong sales of Vafseo and Auryxia, with Vafseo generating $12 million in net revenues. Additionally, H.C. Wainwright initiated coverage of Akebia Therapeutics with a Buy rating, setting a price target of $8.00, highlighting confidence in Vafseo’s market potential. Analysts noted that contracts covering nearly all U.S. dialysis patients will be in place by January 2025, supporting Vafseo’s success. Akebia’s positive cash position, with $113.4 million in cash and equivalents, further strengthens its financial standing. These developments reflect Akebia’s strategic focus on expanding its market presence and advancing its pipeline.

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