Akebia Therapeutics reports Q3 2026 results

Item 2.02. Results of Operations and Financial Condition.

On November 5, 2026, Akebia Therapeutics, Inc. (the "Company") issued a press release announcing its financial results for the third quarter ended September 30, 2026 and recent business highlights.¹ A copy of the Company's press release containing this information is furnished as Exhibit 99.1 to this Current Report on Form 8-K ("Report") and is incorporated herein by reference.

The information in this Report (including Item 2.02 and Exhibit 99.1) shall not be deemed "filed" for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the "Exchange Act"), or otherwise subject to the liabilities of that section, nor shall it be deemed incorporated by reference in any filing under the Exchange Act or the Securities Act of 1933, as amended, except as expressly set forth by specific reference in such a filing.

Item 9.01. Financial Statements and Exhibits.

(d) Exhibits

Exhibit No.

Description

99.1

P ress Release, dated November 5, 2026, issued by Akebia Therapeutics, Inc.

104

Cover Page Interactive Data File (embedded within the Inline XBRL document)

SIGNATURE

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

AKEBIA THERAPEUTICS, INC.

Date: November 5, 2026

By: /s/ John P. Butler

Name: John P. Butler

Title: President and Chief Executive Officer

Akebia Therapeutics Reports Third Quarter 2026 Financial Results and Business Highlights

Positive VOICE data demonstrating statistically significant evidence of improved safety outcomes for patients treated with vadadustat versus an ESA presented by U.S. Renal Care at ASN Kidney Week

Reported Positive VOCAL topline data showing vadadustat met primary endpoint of non-inferiority to ESA in maintaining hemoglobin

First patient dosed in Phase 2 open-label basket trial evaluating ebribafusp alfa in multiple rare kidney diseases; initial data expected in 2027

Strong financial position with approximately $159.3 million in cash and cash equivalents at quarter end

Akebia to host conference call at 8:00 a.m. EST on November 5, 2026

WALTHAM, Mass.—November 5, 2026—Akebia Therapeutics®, Inc. (Nasdaq: AKBA), a biopharmaceutical company with the purpose to better the lives of people impacted by kidney disease, today reported financial results for the third quarter ended September 30, 2026 and shared recent business highlights related to the commercial launch of Vafseo® (vadadustat) and its advancing kidney disease pipeline, including ebribafusp alfa and praliciguat.

"Our strategic commercial priority remains making Vafseo standard of care for the treatment of anemia for patients on dialysis, and we are focused on continuing to increase the number of patients on therapy," said John P. Butler, Chief Executive Officer of Akebia. "Our efforts are energized by the exciting presentation of the positive VOICE trial data by Dr. Block of U.S. Renal Care at ASN Kidney Week last month, in which the findings demonstrated improved safety outcomes for dialysis patients treated with vadadustat three times weekly, an investigational regimen that most dialysis providers have chosen to adopt, compared with those treated with erythropoiesis-stimulating agents (ESA) for CKD anemia. We believe this compelling data has the potential to drive Vafseo to be standard of care. We continue to work to strengthen our market position as we enter 2027 when we believe Vafseo access will expand beyond the Transitional Drug Add-on Payment Adjustment (TDAPA)-only patients to nearly all clinically eligible patients. We will continue to work tirelessly to ensure this innovative product reaches patients, and Vafseo realizes its long-term potential."

Third Quarter and Recent Business Highlights:

• Vafseo net product revenues were $14.8 million in Q3. Approximately 11,500 patients were active on Vafseo at the end of Q3 2026, representing an approximate 8.1% increase from the end of Q2 2026 and an increase of approximately 140 % over Q3 2025.² Total number of prescribers increased to approximately 1,300, representing an increase of over 7% versus Q2 2026 .³

• In November, Akebia announced topline results of VOCAL, an open-label trial Akebia conducted to evaluate the efficacy and safety of three times weekly (TIW) dosing of vadadustat compared to standard of care ESA in patients with anemia due to CKD receiving in-center hemodialysis. VOCAL met the primary endpoint of non-inferiority to ESA based on change in hemoglobin.

• In October at ASN Kidney Week, Dr. Geoffrey A. Block of U.S. Renal Care delivered a late-breaking presentation of the results of the VOICE trial evaluating the safety of TIW dosing of vadadustat compared with an ESA in patients receiving in-center hemodialysis. The data demonstrated a statistically significant improved safety outcome in patients treated with vadadustat versus ESA on the hierarchical composite endpoint of all-cause mortality and hospitalization, driven by a significant reduction in hospitalization rate. At ASN Kidney Week, Akebia presented additional posters reviewing clinical and economic outcomes associated with Vafseo.

• In September, Akebia announced it had dosed the first patient in a Phase 2 open-label basket trial of ebribafusp alfa, which Akebia believes has the potential to be a next-generation complement inhibitor. The trial is designed to evaluate the safety, efficacy, and pharmacokinetics of ebribafusp alfa and is expected to enroll up to 30 patients with C3 glomerulopathy, lupus nephritis or IgA nephropathy. Akebia expects to report initial data from this trial in 2027.

• At ASN Kidney Week, Akebia also presented three posters on its rare kidney disease pipeline, including a poster highlighting preclinical research of praliciguat in focal segmental glomerulosclerosis (FSGS), the Phase 2 trial evaluating praliciguat in FSGS, and the Phase 2 basket trial of ebribafusp alfa in complement-mediated kidney diseases.

"The third quarter brought a meaningful milestone for our rare kidney disease pipeline as we dosed the first patient in our Phase 2 basket trial evaluating ebribafusp. We believe advancing our pipeline assets has the potential to further drive long-term value for shareholders and patients. We are pursuing our commercial and research and development efforts with a disciplined approach to investment and a strong cash position," Mr. Butler said.

Financial Results