Akebia and U.S. Renal Care Halt VOICE Trial
Written by Emily J. Thompson, Senior Investment Analyst
Updated: Jun 30 2026
0mins
Akebia and U.S. Renal Care announced the decision by USRC Kidney Research to stop the Vafseo Outcomes In Center Experience, or VOICE, trial following a planned interim analysis. The primary investigator made the decision to stop the study after a recommendation from the Independent Data Monitoring Committee and Trial Steering Committee based on the prespecified stopping criteria and supported by findings of significantly improved safety outcomes in patients treated with Vafseo dosed three times weekly versus an erythropoiesis-stimulating agent. The VOICE trial enrolled 2,116 patients and was designed as a randomized, open-label, active controlled, non-inferiority trial sponsored by USRC to measure the safety of Vafseo administered TIW versus standard-of-care ESA using a hierarchical composite endpoint of mortality and hospitalization rates. Results of the planned interim analysis as of June 1, the data cutoff date, demonstrated that the trial met the predefined stopping criteria with a win odds of 1.16, establishing non-inferiority and superiority of the primary composite endpoint. The results further demonstrated a statistically significant decrease in hospitalizations with Vafseo versus ESA. There was no statistically significant difference between mortality rates with Vafseo versus ESA.
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Analyst Views on AKBA
Wall Street analysts forecast AKBA stock price to rise
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3 Buy
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Strong Buy
Current: 1.300
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4.00
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5.00
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6.00
Current: 1.300
Low
4.00
Averages
5.00
High
6.00
About AKBA
Akebia Therapeutics, Inc. is a fully integrated biopharmaceutical company with two commercial products for patients impacted by kidney disease. The Company's portfolio includes Vafseo and Auryxia. Vafseo is an orally administered medicine, approved by the United States Food and Drug Administration (FDA), for the treatment of anemia due to chronic kidney disease (CKD) in adult patients on dialysis for at least three months. Auryxia (ferric citrate) is an orally administered medicine approved and marketed in the United States for two indications: the control of serum phosphorus levels in adult patients with dialysis dependent chronic kidney disease (DD-CKD), and the treatment of iron deficiency anemia (IDA) in adult patients with non-dialysis-dependent chronic kidney disease (NDD-CKD). The Company's development pipeline includes mid-stage rare kidney disease pipeline assets (praliciguat and AKB-097) and early-stage pipeline assets (AKB-9090 and AKB-10108), which are HIF molecules.
About the author
Emily J. Thompson
Emily J. Thompson, a Chartered Financial Analyst (CFA) with 12 years in investment research, graduated with honors from the Wharton School. Specializing in industrial and technology stocks, she provides in-depth analysis for Intellectia’s earnings and market brief reports.
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- Vafseo Market Performance: Vafseo net product revenues reached $15.8 million, showing substantial growth compared to the previous quarter, with nearly 7,500 patients using the drug by the end of Q1, indicating an increasing market penetration among dialysis patients and positioning it as a potential standard of care.
- Improved Patient Adherence: Approximately 86% of Vafseo patients demonstrated good adherence rates under observed dosing protocols in Q1, with about two-thirds receiving treatment three times weekly, which is expected to enhance long-term treatment outcomes and brand loyalty for the company.
- Cautious Future Outlook: While management remains optimistic about the TDAPA opportunity for 2026, CEO Butler expressed caution during the Q&A regarding revenue growth forecasts, emphasizing uncertainty in the linearity of growth curves, reflecting concerns over market competition and operational challenges.
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- R&D Day Insights: During its R&D Day, Akebia discussed pipeline progress and strategic focus on kidney disease treatments, emphasizing commitment to future product development, particularly in the $1 billion dialysis market, where significant data catalysts are anticipated.
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Akebia (AKBA) Q4 2025 Earnings Call Transcript
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- Significant Revenue Growth: Akebia Therapeutics reported total revenues of $53.5 million in Q1 2026, exceeding analysts' expectations of $51.67 million, indicating strong performance in Vafseo sales and suggesting potential for increased market share in the future.
- Vafseo Market Performance: Vafseo net product revenues reached $15.8 million, showing substantial growth compared to the previous quarter, with nearly 7,500 patients using the drug by the end of Q1, indicating an increasing market penetration among dialysis patients and positioning it as a potential standard of care.
- Improved Patient Adherence: Approximately 86% of Vafseo patients demonstrated good adherence rates under observed dosing protocols in Q1, with about two-thirds receiving treatment three times weekly, which is expected to enhance long-term treatment outcomes and brand loyalty for the company.
- Cautious Future Outlook: While management remains optimistic about the TDAPA opportunity for 2026, CEO Butler expressed caution during the Q&A regarding revenue growth forecasts, emphasizing uncertainty in the linearity of growth curves, reflecting concerns over market competition and operational challenges.
See More
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- Earnings Shortfall: Akebia Therapeutics reported a Q1 loss of -$0.03 per share, aligning with analyst expectations, but revenue of $53.5 million fell 6% year-over-year, reflecting pressure from declining Auryxia® revenues, which negatively impacted market confidence.
- Product Revenue Shift: Auryxia net product revenues were $36.2 million, while Vafseo net product revenues grew to $15.8 million; despite a 28% increase in prescribers to around 1,025 for Vafseo, the overall revenue decline still adversely affected the company's performance.
- Cash Position: As of March 31, 2026, Akebia had approximately $162.6 million in cash and cash equivalents, indicating a solid cash reserve, but ongoing revenue declines may hinder future operational and investment capabilities.
- Poor Market Performance: Akebia's stock has dropped over 27% year-to-date, contrasting sharply with a 7% rise in broader markets, reflecting investor concerns about the company's future growth potential and possibly leading to further market adjustments.
See More
Akebia Scheduled to Announce Q1 Earnings Results
- Earnings Announcement: Akebia (AKBA) is set to release its Q1 earnings results on May 7 before market open, with consensus EPS estimate at -$0.01 and revenue expected at $51.67 million, reflecting a 9.9% year-over-year decline, indicating challenges in revenue growth.
- Earnings Estimate Adjustments: Over the past three months, EPS estimates have seen no upward revisions and two downward adjustments, while revenue estimates experienced one upward revision and three downward changes, reflecting market caution regarding Akebia's future performance, which may impact investor confidence.
- R&D Day Insights: During its R&D Day, Akebia discussed pipeline progress and strategic focus on kidney disease treatments, emphasizing commitment to future product development, particularly in the $1 billion dialysis market, where significant data catalysts are anticipated.
- Market Focus: With the upcoming earnings report and pipeline expansion, investors will closely monitor Akebia's performance, as the company's strategic positioning and R&D outcomes in a competitive healthcare market will directly influence its stock price trajectory.
See More
Akebia Initiates Phase 1 Trial for AKB-9090 in Cardiac Surgery-Associated AKI
- Trial Launch: Akebia Therapeutics has announced the dosing of the first participants in its Phase 1 clinical trial for AKB-9090, aimed at treating cardiac surgery-associated acute kidney injury, showcasing the company's innovative potential in kidney disease treatment.
- Study Design Details: The trial is a randomized, double-blind, placebo-controlled study designed to enroll up to 70 healthy adult participants to evaluate the safety, tolerability, and pharmacokinetics of AKB-9090, which is expected to provide critical data for future clinical applications.
- Market Demand Opportunity: As a HIF-PH inhibitor targeting acute kidney injury, AKB-9090 addresses a significant unmet medical need, and if successfully developed, it could greatly improve patient outcomes and enhance Akebia's competitiveness in the biopharmaceutical market.
- Future Outlook: Akebia plans to report top-line data in early 2027 to further validate the clinical efficacy of AKB-9090, while also evaluating other kidney disease treatment programs, indicating its ongoing commitment to investment and strategic development in the nephrology field.
See More
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- Stock Performance: Guardian Pharmacy Services (GRDN) shares surged 9.1% in the last trading session to close at $37.25, reflecting heightened investor confidence in its product portfolio and notable trading volume exceeding typical levels.
- Earnings Expectations: The company is expected to report quarterly earnings of $0.24 per share, representing a year-over-year increase of 14.3%, with revenues projected at $329.68 million, up 0.1% from the previous year, indicating sustained competitiveness in the long-term care pharmacy market.
- Estimate Revision Trend: Over the past 30 days, the consensus EPS estimate for GRDN has been revised 4.8% higher, and such positive revision trends are often correlated with stock price appreciation, suggesting potential future gains.
- Market Position: GRDN currently holds a Zacks Rank of #1 (Strong Buy), further reflecting market recognition of its position and growth potential within the medical drugs industry.
See More
Akebia (AKBA) Q4 2025 Earnings Call Transcript
See More
