Akebia Therapeutics (AKBA) Company Report

Akebia Therapeutics, Inc. announced the establishment of its rare kidney disease pipeline on December 1, 2025, which includes two core product candidates: AKB-097 and praliciguat.
The company acquired global rights to AKB-097 from Q32 Bio Inc. for an upfront payment of $7.0 million and an additional $3.0 million due in six months.
Akebia will also make potential milestone payments for AKB-097, including up to $94.5 million for development and regulatory milestones and up to $487.5 million for commercial milestones, plus tiered royalties on net sales.
Phase 2 trials for both AKB-097 and praliciguat are planned to start treating subjects in 2026, with initial clinical data from the AKB-097 trial expected in 2027.
The initiation of the praliciguat Phase 2 clinical trial triggers a $1.0 million regulatory milestone payment to Cyclerion Therapeutics, Inc..

4 days ago

8-K

Q32 Bio Sells Complement Inhibitor ADX-097 to Akebia Therapeutics

AKBA

M&A

New Projects/Investments

Guidance Update

Q32 Bio sold its Phase 2 complement inhibitor, ADX-097, to Akebia Therapeutics.
Q32 Bio will receive $12 million in upfront and near-term milestone payments, with potential for up to $592 million in total milestones and tiered royalties up to a mid-teen percent of annual net sales.
This transaction is expected to extend Q32 Bio's cash runway into the second half of 2027 and allows the company to focus on advancing bempikibart for alopecia areata.

4 days ago

Press Release

Akebia Therapeutics Amends Vafseo License Agreement with Medice

AKBA

New Projects/Investments

On November 12, 2025, Akebia Therapeutics, Inc. and MEDICE Arzneimittel Putter GmbH & Co. KG (Medice) entered into Amendment #1 to their License Agreement.
Under this amendment, Akebia Therapeutics will supply vadadustat drug substance to Medice.
Medice has been granted the right to manufacture Vafseo tablets using the supplied drug substance.
Akebia Therapeutics will retain ownership of any know-how or patent rights developed from Medice's manufacturing of Vafseo tablets.

Nov 17, 2025, 12:54 PM

8-K

Akebia Provides Vafseo Launch Update and Financial Outlook

AKBA

Product Launch

New Projects/Investments

Guidance Update

Akebia's Vafseo launch is progressing, with DaVita opening product access to all its dialysis centers as of November 10. The company expects to increase patient access from 40,000 in the first half of the year to 260,000-275,000 by year-end, anticipating significant growth into 2026.
U.S. Renal Care is transitioning to three times a week (TIW) dosing for Vafseo, which is expected to improve adherence and long-term business, though this transition and inventory adjustments may impact Q4 revenue.
A win odds analysis of the INNO2VATE Phase 3 study demonstrated a statistically significant lower risk of dying or being hospitalized for patients treated with Vafseo compared to darbepoetin, supporting its potential as a standard of care.
Akebia reported $166 million in cash as of the end of Q3 and has guided that it is financed to profitability, considering estimated revenues and pipeline expenses.

Nov 17, 2025, 12:00 PM

Transcript

Akebia Provides Vafseo Launch Update, Financial Position, and Pipeline Outlook

AKBA

Product Launch

Guidance Update

New Projects/Investments

Akebia's Vafseo launch for dialysis patients is progressing well, with patient access expected to grow from 40,000 to 260,000-275,000 by year-end 2025. DaVita opened Vafseo access to all its dialysis centers as of November 10, 2025.
U.S. Renal Care, a major dialysis provider, is moving to three times a week (TIW) dosing for Vafseo, which is expected to improve patient adherence and is viewed as beneficial for long-term business, despite not being in the product's label.
Akebia has a strong balance sheet with $166 million in cash as of the end of Q3 2025 and is financed to profitability, accounting for estimated revenues and pipeline advancement expenses.
While the opportunity for Vafseo in the non-dialysis dependent (NDD) patient population faced a setback due to FDA feedback, Akebia plans to advance AKB-9090 for acute kidney injury into first-in-man studies early next year.

Nov 17, 2025, 12:00 PM

Transcript

Akebia Provides Vafseo Launch Update and Financial Outlook

AKBA

Product Launch

Guidance Update

New Projects/Investments

Akebia reported positive progress for its Vafseo launch in dialysis patients, noting significant access expansion from 40,000 to 260,000-275,000 dialysis patients by year-end, driven by adoption at U.S. Renal Care and DaVita.
The company is addressing operational challenges and adherence issues by supporting three-times-a-week (TIW) dosing for Vafseo, which aligns with existing clinical practice and is supported by data.
Akebia maintains a strong balance sheet with $166 million in cash as of the end of Q3 and has guided that it is financed to profitability, considering estimated revenues and pipeline expenses.
The company plans to continue engaging the FDA regarding the non-dialysis dependent (NDD) patient population for Vafseo and is advancing its early-stage pipeline, including AKB 9090 for acute kidney injury.

Nov 17, 2025, 12:00 PM

Transcript

Akebia Therapeutics Discusses Vafseo Commercial Progress and Financial Position

AKBA

Product Launch

Guidance Update

New Projects/Investments

Akebia Therapeutics reported $14.3 million in revenue for Vafseo in the recent quarter, noting significant progress in market access, including DaVita expanding access to over 4,000 dialysis centers as of November 10th.
The company emphasized the role of TDAPA (Transitional Drug Add-on Payment Adjustment) in allowing Vafseo to be sold at a higher price for two years, and views the anemia market as a billion-dollar opportunity in the U.S..
Recent data presented at ASN demonstrated a statistically significantly lower risk of mortality or hospitalization with Vafseo compared to ESAs, with ongoing studies like VOICE expected to provide further differentiation.
Akebia ended the quarter with $166 million on the balance sheet and has guided that it is financed to profitability, while also advancing its pipeline with AKB-9090 targeting acute kidney injury and AKB-10108 for retinopathy of prematurity.

Nov 10, 2025, 8:00 PM

Transcript

Akebia Therapeutics Reports Q3 2025 Financial Results

AKBA

Earnings

Product Launch

Revenue Acceleration/Inflection

Akebia Therapeutics reported total revenues of $58.8 million for the third quarter of 2025, an increase from $37.4 million in the third quarter of 2024, primarily driven by sales of Vafseo and Auryxia.
Vafseo net product revenues reached $14.3 million in Q3 2025. The company anticipates increasing total prescribing access for Vafseo to 275,000 patients by the end of the year, up from 60,000 patients at the end of Q3 2025.
The company achieved net income of $0.5 million in the third quarter of 2025, a significant improvement compared to a net loss of $20.0 million in the third quarter of 2024.
As of September 30, 2025, Akebia's cash and cash equivalents were approximately $166.4 million.
Akebia does not plan to initiate the VALOR clinical trial and will not pursue a broad label for Vafseo for CKD non-dialysis dependent patients following a lack of alignment with the FDA.

Nov 10, 2025, 12:04 PM

8-K

Akebia Therapeutics Reports Strong Q3 2025 Financial Results and Vafseo Progress

AKBA

Earnings

Product Launch

Revenue Acceleration/Inflection

Akebia Therapeutics reported total revenues of $58.8 million for the third quarter of 2025, an increase from $37.4 million in Q3 2024, and achieved a net income of $0.5 million compared to a net loss of $20.0 million in the prior year period.
Vafseo net product revenues were $14.3 million in Q3 2025, with an operational pilot at DaVita expected to complete in the fourth quarter and prescribing access anticipated to reach 275,000 patients by year-end.
The company ended Q3 2025 with $166.4 million in cash and cash equivalents and believes it is financed to achieve profitability based on its current operating plan.
Akebia does not plan to pursue a broad label for Vafseo for non-dialysis dependent patients, as it did not achieve alignment with the FDA on a proposed path forward for a Phase 3 clinical trial.

Nov 10, 2025, 12:00 PM

Press Release

Akebia Therapeutics Presents Favorable Vafseo Clinical Trial Results

AKBA

New Projects/Investments

Revenue Acceleration/Inflection

Akebia Therapeutics announced the presentation of a post-hoc win odds analysis from its Phase 3 INNO2VATE trials of Vafseo (vadadustat), demonstrating favorable and statistically significant effects on the composite endpoint of death or hospitalization compared to darbepoetin alfa.
The analysis, presented at ASN Kidney Week 2025, showed that patients randomized to vadadustat experienced a lower risk of death or hospitalization.
Specifically, the inverted win-odds ratio for "on treatment + 28 days post last dose" was 0.86 (95% CI: 0.81, 0.95; p <0.0001), indicating a statistically significant benefit for vadadustat.
Vafseo is approved for the treatment of anemia due to chronic kidney disease in adults receiving dialysis and has been available in the U.S. since January 2025.

Nov 6, 2025, 11:30 PM

Press Release

Earnings Transcripts

Quarterly earnings call transcripts for Akebia Therapeutics.

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