Akebia's Stock Drops After Decision to Discontinue Vafseo for Non-Dialysis Patients
Written by Emily J. Thompson, Senior Investment Analyst
Updated: Oct 28 2025
0mins
Should l Buy AKBA?
Source: SeekingAlpha
Akebia's Decision: Akebia Therapeutics has abandoned plans to expand the indication for Vafseo to treat anemia in chronic kidney disease patients not on dialysis after the FDA rejected its trial design proposal.
Impact on Shares: Following the announcement, Akebia's shares fell by 19% in after-hours trading.
Regulatory Challenges: The company indicated that the FDA's feedback suggested a need for a larger patient population for the VALOR trial, which would increase both time and costs.
Current Status of Vafseo: Vafseo was approved by the FDA in 2024 solely for dialysis patients, generating $13.3 million in revenue in Q2, with Q3 financial results expected on November 6.
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Analyst Views on AKBA
Wall Street analysts forecast AKBA stock price to rise
3 Analyst Rating
3 Buy
0 Hold
0 Sell
Strong Buy
Current: 1.360
Low
4.00
Averages
5.00
High
6.00
Current: 1.360
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). Its HIF-based product candidates and other pipeline assets are being evaluated to target areas of unmet needs. Its product candidates include AKB-9090, AKB-10108, AKB-097 and praliciguat.
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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- Patient Recruitment: Approximately 60 patients will be randomized to receive either Praliciguat or placebo for a 24-week treatment period, after which all participants will transition to an open-label extension to further assess the drug's long-term effects.
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- Trial Initiation: Akebia Therapeutics has announced the dosing of the first patient in the Phase 2 clinical trial of Praliciguat, its lead drug candidate for FSGS, potentially addressing the needs of approximately 40,000 patients in the U.S. without approved treatments.
- Study Design: This randomized, double-blind, placebo-controlled multicenter study aims to evaluate the efficacy and safety of Praliciguat in reducing the risk of kidney failure, primarily monitoring changes in the urine protein-to-creatinine ratio, which is critical for clinical outcomes.
- Patient Recruitment: Approximately 60 patients will be randomized to receive either Praliciguat or placebo for a 24-week treatment period, after which all participants will transition to an open-label extension to further assess the drug's long-term effects.
- Product Portfolio: Akebia is also advancing other candidates like Vafseo, currently in Phase III development, and AKB-9090 for treating acute kidney injury, indicating a robust pipeline in the renal disease sector.
See More
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- Patient Enrollment and Design: The trial aims to enroll approximately 60 patients, who will be randomized to receive either praliciguat or placebo for an initial 24-week treatment period, designed to evaluate the drug's efficacy and safety.
- Market Demand: FSGS affects around 40,000 patients in the U.S. with no approved treatments available, and the development of praliciguat is poised to fill this market gap, addressing urgent patient needs.
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See More
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- Incentive Structure: The options vest over four years, with 25% vesting on the first anniversary and the remaining 75% vesting quarterly, ensuring the employee's continued contribution during their tenure, which is expected to boost loyalty and engagement.
- Regulatory Compliance: This options grant adheres to Nasdaq Listing Rule 5635(c)(4), demonstrating Akebia's compliance and transparency in talent acquisition, thereby enhancing investor confidence in the company's governance practices.
- Long-term Strategy: By implementing an inducement options program, Akebia not only attracts key talent but also lays the groundwork for future R&D and market expansion, supporting the company's long-term growth in the kidney disease treatment sector.
See More
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Details on ADX-097: ADX-097 is a humanized anti-C3d Factor H monoclonal antibody designed to inhibit complement activation, with applications in various diseases, including kidney and autoimmune conditions.
Future Plans for Q32 Bio: Q32 Bio retains rights to its tissue-targeted complement inhibitor platform and is exploring strategic options for its remaining assets, expecting to fund operations into the second half of 2027 with the proceeds from the ADX-097 sale.
See More
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- Strategic Focus Maintained: Q32 Bio retains its wholly owned tissue-targeted complement inhibitor platform, including ADX-096 and other early-stage assets, while continuing to evaluate strategic options for these programs, ensuring ongoing innovation and development in its core technology area.
- Strong Market Demand: With alopecia areata affecting approximately 700,000 individuals, Q32 Bio's bempikibart is poised to transform the treatment landscape, addressing the urgent need for effective therapies and further solidifying its market position in the biotechnology sector.
See More
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- Clinical Trial Initiation: Akebia plans to initiate a Phase 2 clinical trial for AKB-097 in 2026, with preliminary clinical data expected in 2027, further advancing its product development pipeline.
- Multiple Indication Evaluation: As a targeted complement inhibitor, AKB-097 aims to address multiple complement-mediated rare kidney diseases, potentially significantly improving patient outcomes and filling a market gap.
- Strategic Development: Akebia's CEO emphasized that establishing a kidney disease drug pipeline is central to the company's strategy, aiming to enhance the quality of life for kidney disease patients and drive long-term growth for the company.
See More
