FDA Resistance Leads Akebia to Abandon Efforts for Expansive Label on Kidney Disease Medication
Written by Emily J. Thompson, Senior Investment Analyst
Updated: Oct 29 2025
0mins
Should l Buy AKBA?
Source: Benzinga
Stock Performance: Akebia Therapeutics Inc. (NASDAQ: AKBA) shares fell by 25.71% to $2.29 following disappointing news regarding their VALOR trial design discussions with the FDA.
FDA Meeting Outcome: The company did not reach an agreement with the FDA on the VALOR trial, which aimed to use vadadustat for treating anemia in late-stage chronic kidney disease patients not on dialysis.
Regulatory Challenges: Akebia anticipates that regulatory alignment for the trial would require a larger patient population than initially proposed, leading to increased time and costs.
Decision on Broad Label: CEO John P. Butler stated that the decision not to pursue a broad label for Vafseo in non-dialysis dependent CKD patients is in the best interest of shareholders.
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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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- 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.
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- Trial Initiation: Akebia Therapeutics has successfully dosed the first patient in its Phase 2 clinical trial for praliciguat targeting FSGS, marking a significant advancement in the treatment of rare kidney diseases.
- 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.
- Safety Profile: Previous Phase 1 and Phase 2 studies have shown praliciguat to have a favorable safety profile with no significant adverse events reported, establishing a solid foundation for its application in rare kidney disease treatment.
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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.
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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
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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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- Trial Initiation: Akebia Therapeutics has successfully dosed the first patient in its Phase 2 clinical trial for praliciguat targeting FSGS, marking a significant advancement in the treatment of rare kidney diseases.
- 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.
- Safety Profile: Previous Phase 1 and Phase 2 studies have shown praliciguat to have a favorable safety profile with no significant adverse events reported, establishing a solid foundation for its application in rare kidney disease treatment.
See More
Akebia Grants 197,900 Stock Options to New Employee
- Options Grant: Akebia Therapeutics granted 197,900 stock options to a new employee on December 31, 2025, with an exercise price of $1.61 per share, reflecting the company's commitment to attracting talent to enhance its team strength in advancing kidney disease treatments.
- 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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Q32 Bio Stock Performance: Q32 Bio Inc. (NASDAQ: QTTB) saw a significant increase in stock price, rising 115.07% to $4.71, with a trading volume of 70.56 million shares compared to its average of 217.704 thousand.
Sale of ADX-097: The company sold its Phase 2 complement inhibitor, ADX-097, to Akebia Therapeutics Inc. (NASDAQ: AKBA) for $12 million upfront, with potential total payments reaching up to $592 million based on future milestones and royalties.
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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- Cash Runway Extended: Q32 Bio's sale of its Phase 2 complement inhibitor ADX-097 to Akebia Therapeutics secures $12 million in upfront and near-term milestone payments, extending its cash runway into the second half of 2027, ensuring continued investment in advancing bempikibart for alopecia areata.
- Significant Potential Earnings: The transaction allows Q32 Bio to potentially receive up to $592 million upon achieving specific development, regulatory, and commercial milestones, highlighting the product's market potential and future profitability.
- 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
Akebia Acquires Q32 Bio's Next-Gen Kidney Disease Treatment
- Acquisition of New Drug: Akebia acquired AKB-097 from Q32 Bio for $7 million, which is expected to be utilized in treating various rare kidney diseases, thereby enhancing its competitive position in the renal market.
- 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
