Akebia Therapeutics (NASDAQ:AKBA) reported second-quarter revenue growth for its Vafseo anemia treatment while highlighting an interim clinical result from the VOICE study and progress across its kidney disease pipeline.
Vafseo net product revenue reached $21.3 million in the second quarter of 2026, up 34% sequentially and 60% from $13.3 million in the prior-year period. The company said it surpassed 10,500 active patients receiving the treatment during the quarter, with total patients on therapy increasing about 41% from the first quarter.
VOICE Trial Met Stopping Criteria
Chief Executive Officer John Butler said an interim analysis of the VOICE trial showed Vafseo achieved a statistically significant and clinically meaningful reduction in the study’s primary composite endpoint of all-cause mortality and hospitalization. The result was driven by a 10% reduction in hospitalization, he said.
The independent data monitoring committee and trial steering committee recommended stopping the trial after the planned interim analysis. The 2,116-patient study met its predefined stopping criteria as of June 1, with a win odds of 1.16 and a p-value of 0.0016, establishing both non-inferiority and superiority on the primary composite endpoint, according to the company.
Butler said the data were consistent with a post-hoc analysis from the Phase III INNO2VATE program published earlier this year. He said the results were consistent across daily and three-times-weekly dosing and against both long-acting and short-acting erythropoiesis-stimulating agents, or ESAs.
Akebia has so far shared the VOICE results through a press release. Butler said study investigator Dr. Geoff Block is working to present the data at a medical meeting and publish them in a peer-reviewed journal.
Commercial Adoption Expands
Chief Commercial Officer Nick Grund said the number of Vafseo prescribers rose 17% from the first quarter, while new patient starts reached their highest quarterly level since the product’s launch period. Approximately one-third of Vafseo prescribers are now affiliated with large dialysis organizations outside U.S. Renal Care, or USRC, he said.
USRC, Innovative Renal Care and Dialysis Clinic Inc. contributed the largest share of patient growth, according to Grund. He said the company sees additional opportunity within those organizations, while DaVita remains its largest potential source of growth from a single dialysis provider.
Akebia said DaVita rolled out its three-times-weekly observed dosing protocol across its network in early June. Grund said the company does not expect a meaningful increase in DaVita adoption during the third quarter, but management cited increased engagement with DaVita’s senior clinical team around operational implementation and said it expects more substantial growth later in the year and into 2027.
On adherence, Grund said about 89% of patients receiving a Vafseo prescription obtain their first refill. Subsequent discontinuation trends more closely resemble normal turnover in the dialysis population, he said, including hospitalizations, tolerability issues and transitions back to ESAs.
Rare Kidney Disease Pipeline Advances
Akebia initiated a Phase II open-label basket trial of ebribafusp, formerly known as AKB-097 and ADX-097, in IgA nephropathy, lupus nephritis and C3 glomerulopathy. The company expects to enroll up to 30 patients in the study, which will evaluate once-weekly subcutaneous dosing for 26 weeks followed by a long-term extension for responders.
Chief Medical Officer Dr. Steven Burke said the trial’s primary endpoint is adverse events, with secondary measures including changes in proteinuria and kidney function. The study will also assess pharmacokinetics and complement biomarkers in blood and urine. Akebia expects to report initial results in 2027.
The company believes ebribafusp could offer tissue-specific complement inhibition at affected kidney glomeruli while avoiding systemic complement inhibition in the blood. Burke said the potential profile could support long-term treatment and possible combinations with B-cell-directed therapies, though he noted that further study will be needed.
Akebia also continues to enroll patients in a Phase II trial of praliciguat for focal segmental glomerulosclerosis, or FSGS. The randomized, double-blind, placebo-controlled study is designed to enroll up to 60 patients with primary or genetic FSGS. Its primary endpoint is the change in urine protein-creatinine ratio from baseline through week 24.
Butler said enrollment is progressing in what he described as a competitive clinical-trial environment, though the company did not provide a timeline for the data readout. Burke said praliciguat’s soluble guanylate cyclase mechanism differs from that of sparsentan and could potentially support future combination approaches.
A third clinical candidate, AKB-9090, remains in a Phase I single-ascending-dose and multiple-ascending-dose study in healthy volunteers. Akebia expects to report data early next year and said it plans to focus development resources in 2027 on ebribafusp and praliciguat.
Financial Position and Pricing Outlook
Akebia reported a net loss of $8.9 million for the second quarter, compared with net income of $0.2 million a year earlier. Research and development expense rose to $14.1 million from $11 million, while selling, general and administrative expense increased to $28.2 million from $26.6 million. The company said the quarter included a $1.9 million expense related to a commercial reorganization.
Cash and cash equivalents totaled approximately $155.5 million as of June 30, down from $162.6 million at the end of the first quarter. Chief Financial and Chief Business Officer Erik Ostrowski said Akebia believes its cash, expected product and other revenues, and a planned refinancing of its senior secured term loan facility will fund its operating plan for at least two years.
Ostrowski also reiterated that Akebia expects Vafseo’s TDAPA period to end Dec. 31, 2026. The company plans to price Vafseo within the range of ESAs afterward, a level significantly below its current price. While Akebia expects Vafseo unit volume to increase in 2027, it expects revenue from the drug to decline from 2026 levels because of the planned price reduction.
About Akebia Therapeutics (NASDAQ:AKBA)
Akebia Therapeutics, Inc, a clinical-stage biopharmaceutical company headquartered in Cambridge, Massachusetts, is focused on the development and commercialization of therapies for patients with kidney disease. The company’s lead product candidate, vadadustat, is an investigational oral hypoxia-inducible factor prolyl hydroxylase inhibitor designed to treat anemia associated with chronic kidney disease in both dialysis-dependent and non-dialysis patients. Akebia’s research and development efforts also extend to preclinical programs targeting nephrology and related metabolic disorders.
Since its founding in 2007, Akebia has pursued strategic collaborations to advance its clinical pipeline and expand its market reach.
