Every 8-K that Akebia Therapeutics, Inc. (AKBA) has filed with the SEC in the last 24 months is listed below, newest first, and each one links through to the document itself with the summary and the scores our analysis gives it.
A 8-K covers material events a company has to report between its quarterly reports, so if you follow AKBA and want that one kind of document rather than the whole filing history, this is the page to keep. The company's other filings, of every form, are on the full AKBA filings page.
Akebia Therapeutics reported second quarter 2026 results with total revenues of $49.1 million, down from $62.5 million a year earlier, as Auryxia sales declined due to generic competition. Vafseo net product revenue increased to $21.3 million from $13.3 million, while Auryxia revenue fell to $25.5 million from $47.2 million. The company recorded a net loss of $8.9 million, compared with net income of $0.2 million in the prior-year quarter. Cash and cash equivalents were $155.5 million as of June 30, 2026.
Commercially, more than 10,500 patients were on Vafseo in the quarter, with prescribers rising to about 1,200. An interim analysis of the 2,116-patient VOICE trial showed statistically significant improved safety outcomes for Vafseo versus an ESA (win odds 1.16; 95% CI 1.06–1.28; p=0.0016). Akebia also initiated a Phase 2 open-label basket trial of ebribafusp for several rare kidney diseases, continued enrolling a Phase 2 trial of praliciguat in FSGS, and strengthened Vafseo’s patent estate with a new Orange Book–listed patent and potential patent term extension. Operating expenses included $1.9 million of restructuring charges related to commercial reorganization.
Akebia Therapeutics reported interim results from the VOICE trial of Vafseo in dialysis patients with anemia due to chronic kidney disease. The randomized, active-controlled safety study in 2,116 patients met predefined stopping criteria, showing Vafseo was both non-inferior and superior to an erythropoiesis-stimulating agent on the primary composite endpoint of all-cause mortality and hospitalization.
The interim analysis as of June 1, 2026 showed a win odds of 1.16 (95% CI 1.06, 1.28, p=0.0016). Hospitalizations were lower with Vafseo at 1.11 versus 1.23 per patient-year, with an incidence rate ratio of 0.90 (95% CI 0.824, 0.988), while mortality rates were similar between groups at 8.77% versus 8.78% per 100 patient-years.
Akebia Therapeutics’ stockholders held their 2026 annual meeting and approved several corporate matters. They elected three Class III directors – Adrian Adams, Michael Rogers and LeAnne M. Zumwalt – to serve until the 2029 annual meeting. Stockholders also approved a Share Increase Amendment to the certificate of incorporation, raising authorized capital stock from 375,000,000 to 525,000,000 shares and authorized common stock from 350,000,000 to 500,000,000 shares, with 102,504,108 votes for and 88,853,129 against. In advisory votes, stockholders approved named executive officer compensation and recommended that say-on-pay votes occur every year. They also ratified Ernst & Young LLP as independent registered public accounting firm for the fiscal year ending December 31, 2026.
Akebia Therapeutics reported a net loss of $9.1 million in the first quarter of 2026, reversing from net income of $6.1 million a year earlier. Total revenues were $53.5 million, down from $57.3 million, as lower Auryxia sales more than offset growth from Vafseo.
Vafseo net product revenues rose to $15.8 million from $12.0 million, helped by an approximate 60% increase in patients on therapy versus the end of Q4 2025 and about 28% more prescribers. Auryxia net product revenues declined to $36.2 million from $43.8 million, with the company expecting generic competition to expand and further reduce 2026 Auryxia revenues.
Operating costs increased as Akebia invested in its kidney disease pipeline, including Phase 2 trials for praliciguat and AKB-097 and a Phase 1 study of AKB-9090. Research and development expenses rose to $14.8 million and selling, general and administrative expenses to $30.4 million. Cash and cash equivalents were $162.6 million as of March 31, 2026, and the company expects these resources and cash from operations to fund its current operating plan for at least two years.
Akebia Therapeutics announced a Board change, with Steven C. Gilman, Ph.D. resigning as a Class I director effective April 1, 2026, stating his resignation is not due to any disagreement with the company. The Board elected Philip J. Vickers, Ph.D. as a new Class I director effective the same date, with an initial term running through the 2027 annual meeting of stockholders.
Dr. Vickers will serve on the Compensation Committee and the Research & Development Committee and will be compensated under Akebia’s non-employee director program. He is eligible for annual cash retainers of $50,000 for Board service, $7,500 for Compensation Committee membership, and $5,000 for Research & Development Committee membership, plus future annual equity grants of options to purchase 53,600 shares and 35,700 restricted stock units starting at the 2027 annual meeting. As a new director, he received a one-time grant of 214,400 stock options on April 1, 2026 at an exercise price of $1.41 per share.
Akebia Therapeutics reported higher fourth quarter and full-year 2025 results, driven mainly by Vafseo and Auryxia. Total revenue rose to $57.6 million in Q4 2025 from $46.5 million a year earlier and to $236.2 million for 2025 from $160.2 million in 2024. Vafseo net product revenue reached $45.8 million in its first full year, while Auryxia generated $181.5 million. Net loss narrowed sharply to $5.3 million for 2025 from $69.4 million in 2024, helped by higher sales and lower amortization charges. Cash and cash equivalents increased to $184.8 million at December 31, 2025, from $51.9 million a year earlier, and the company expects current cash and operating cash flow to fund its plan for at least two years. Management anticipates significant Vafseo revenue growth in 2026 but expects Auryxia revenue to decline as generic competition expands, while advancing multiple Phase 2 and Phase 3 trials in rare kidney diseases.
Akebia Therapeutics entered into a long-term lease to relocate its corporate headquarters to new office and lab space in Waltham, Massachusetts. The lease covers approximately 43,474 square feet and includes an initial annual rent of $898,317 for the office area and $1,046,920 for the lab area, subject to scheduled yearly increases. The initial term runs 84 months from the office commencement date, with a security deposit of $810,515 provided via letter of credit and an option for a five-year extension.
Akebia also approved amended executive severance agreements for its CEO, John P. Butler, and CFO, Erik J. Ostrowski, to better align with market practices. These agreements provide specified periods of salary continuation, bonus payments, COBRA premium reimbursements, and accelerated vesting of equity awards upon certain terminations, particularly in connection with a change in control, contingent on a release of claims and ongoing restrictive covenants.
Akebia Therapeutics, Inc. furnished an update focused on its Vafseo® (vadadustat) commercial business and future growth plans. The company issued a press release outlining key corporate updates, an outlook on upcoming milestones, and highlighted its next anticipated growth driver in its mid-stage rare kidney disease pipeline. It also shared an overview of expected fourth quarter 2025 Vafseo net product revenue.
Akebia is also making a corporate presentation available, which its spokespersons plan to use at investor and analyst meetings, including sessions coinciding with the 44th Annual J.P. Morgan Healthcare Conference. Both the press release and the presentation are attached as exhibits and are being furnished, not filed, under the securities laws.
Akebia Therapeutics, Inc. entered into an amendment to its existing license agreement with Medice Arzneimittel Putter GmbH & Co. KG related to Vafseo, its treatment for anemia in chronic kidney disease. The amendment, dated November 12, 2025, adds a new supply and manufacturing structure.
Under the amendment, Akebia will supply vadadustat drug substance to Medice under a separate supply agreement, and Medice is granted the right to manufacture Vafseo tablets using that material. Any new know-how or patent rights that arise from Medice’s manufacturing activities will be owned by Akebia, helping Akebia retain control over future intellectual property linked to Vafseo tablet production in the licensed territories.
Akebia Therapeutics, Inc. filed a current report to furnish a press release announcing its financial results for the third quarter ended September 30, 2025 and recent business highlights. The company issued the press release on November 10, 2025, and attached it as Exhibit 99.1. The report clarifies that the information in Item 2.02 and Exhibit 99.1 is being furnished rather than filed under the Exchange Act, so it is not subject to Section 18 liability and will only be incorporated into other SEC filings if specifically referenced. Akebia’s common stock, par value $0.00001 per share, trades on The Nasdaq Capital Market under the symbol AKBA.
Akebia Therapeutics (AKBA) announced a strategic setback. After meeting with the U.S. Food and Drug Administration, the company did not reach alignment on the design of the VALOR clinical trial evaluating vadadustat for anemia in late-stage chronic kidney disease patients not on dialysis. As a result, Akebia does not plan to initiate VALOR and does not expect to pursue a broad U.S. label for Vafseo in non-dialysis dependent CKD.
This decision narrows the company’s near-term U.S. regulatory path for vadadustat in the non-dialysis setting and shifts focus away from a broad label expansion. The disclosure was made under Regulation FD and as an Other Event, highlighting its significance to the company’s clinical and commercial strategy.