CAMBRIDGE, Mass. - Akebia Therapeutics, Inc. (NASDAQ:AKBA), a biopharmaceutical firm focused on kidney disease treatments, along with U.S. Renal Care, announced the initiation of a clinical trial for Vafseo in patients undergoing dialysis. The VOICE trial, involving about 2,200 patients, will compare the effects of Vafseo to standard erythropoiesis-stimulating agents, with patient enrollment expected to commence within this year.
The trial's main goal is to evaluate all-cause mortality and hospitalizations among participants. With a dosing regimen of 300 mg tablets three times weekly, the study is designed to demonstrate non-inferiority in mortality and a 10% reduction in hospitalizations compared to the current standard of care. The trial will conclude approximately 18 months after the last patient has been randomized.
Dr. Steven K. Burke, Chief Medical Officer of Akebia, expressed optimism about the collaboration with U.S. Renal Care and the potential of Vafseo to align with dialysis schedules, building upon previous safety and efficacy evidence. Dr. Geoffrey A. Block of U.S. Renal Care highlighted the significance of real-world evidence to evaluate the benefits and risks of treating anemia in chronic kidney disease with Vafseo.
Vafseo, approved in 37 countries, is a once-daily oral treatment for anemia due to chronic kidney disease in adults on dialysis for at least three months. However, it is not indicated for immediate anemia correction or for patients not on dialysis. The drug carries warnings for increased risk of serious cardiovascular events and is contraindicated in certain conditions, such as uncontrolled hypertension.
The company has cautioned against expectations of improved quality of life or patient well-being with Vafseo and advises the lowest effective dose to reduce red blood cell transfusions. The press release statement also includes information on adverse reactions, drug interactions, and specific population use.
Akebia has made forward-looking statements regarding the VOICE trial and Vafseo's potential, emphasizing the importance of building evidence for the treatment's benefits in the real-world setting. The results of this trial are anticipated to contribute to the understanding of Vafseo's safety profile when administered alongside dialysis treatments.
In other recent news, Akebia Therapeutics ended its collaboration with CSL (OTC:CSLLY) Vifor and amended its loan terms with Kreos Capital VII, managed by BlackRock Inc (NYSE:BLK). The termination and settlement agreement, effective immediately, was based on business reasons. As part of the termination, Akebia Therapeutics and CSL Vifor structured a repayment plan for the $40 million working capital fund. The company will commence quarterly tiered royalty payments to CSL Vifor starting July 1, 2025.
In addition, Akebia Therapeutics regained full sales rights to Vafseo in the United States. The company disclosed the wholesale acquisition cost for Vafseo at $1,278 for a 30-day supply and expects full designation by 2025.
The company also announced the appointment of Erik Ostrowski as Senior Vice President, Chief Financial Officer, Chief Business Officer, Treasurer, and Principal Financial (NASDAQ:PFG) Officer. Ostrowski's diverse experience in biotechnology finance is expected to be beneficial to the company.
On the financial front, Akebia reported Q1 2024 revenues of $32.6 million, showing an improvement from the previous year, despite a net loss of $18 million. The company remains well-capitalized with $42 million in cash and equivalents. These are the recent developments regarding Akebia Therapeutics.
InvestingPro Insights
As Akebia Therapeutics (NASDAQ:AKBA) embarks on the VOICE trial for its Vafseo treatment, the company's financial health and market performance provide essential context for investors and industry observers. With a market capitalization of $293.35 million, Akebia remains a notable player in the biopharmaceutical space, particularly in the kidney disease treatment sector.
InvestingPro Tips highlight a mixed sentiment around Akebia's stock. Analysts have revised their earnings upwards for the upcoming period, signaling a potential positive outlook on the company's financial prospects. However, it is important to note that the company is not expected to be profitable this year and has not been profitable over the last twelve months. This aligns with the company's significant investment in research and development, as evidenced by the initiation of the VOICE trial.
InvestingPro Data further reveals the company's financial metrics, with a negative P/E Ratio of -6.76, indicating that the stock might be undervalued by traditional earnings measures due to the lack of profitability. The revenue of $174.5 million over the last twelve months, despite showing a decline of 13.13%, still reflects the company's ability to generate substantial sales. Most notably, the gross profit margin stands at a strong 82.29%, suggesting that Akebia maintains a high level of operational efficiency in its cost of goods sold.
Investors may also consider the stock's recent performance, where it has experienced a strong return over the last month (17.72%) and three months (26.82%), despite a significant hit over the last week (-8.22%). These fluctuations underscore the volatility and the high-risk, high-reward nature of investing in biopharmaceutical firms like Akebia.
For those interested in exploring more about Akebia Therapeutics, additional InvestingPro Tips are available, offering comprehensive analyses and forecasts. There are currently 7 more tips listed on InvestingPro, which can be accessed for deeper insights into Akebia's performance and potential investment opportunities.
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