Akebia Therapeutics (NASDAQ:AKBA) outlined its commercial priorities for Vafseo, the expected evolution of reimbursement after the TDAPA period and several renal-disease pipeline programs during a fireside chat at the Jefferies 2026 Global Healthcare Conference.
Erik, Akebia’s chief financial officer, described the company as a commercial-stage kidney disease business with two marketed products and an advancing pipeline. He said Akebia’s main commercial focus is Vafseo, approved for anemia caused by chronic kidney disease in patients on dialysis. The company also markets Auryxia, a phosphate binder that lost intellectual property exclusivity last year and is expected to become a smaller part of the business, though Erik said it continues to generate cash flow.
Vafseo Launch Shows Broader Prescriber Uptake
Grund said roughly 1,028 physicians had prescribed Vafseo, a 28% increase, reflecting a more diversified prescriber base beyond U.S. Renal Care and into groups including IRC, DCI and DaVita physicians. He also said the number of patients on Vafseo rose 60% quarter over quarter, with most of that increase occurring in March.
Grund said DaVita remains a major opportunity, describing it as the “200,000 patient gorilla” in the market. While Akebia has access to DaVita, he said the organization is taking a more cautious approach and is piloting and implementing three-times-weekly, or TIW, protocols across many clinics. Grund said DaVita adoption is expected to be “a second half story.”
TIW Dosing Seen as Important for Refills
Grund said TIW dosing has improved early refill trends. He noted that dialysis patients have high underlying churn because roughly 20% die each year due to dialysis and CKD, and some patients also leave treatment after receiving transplants. He estimated underlying churn at about 2% to 4% per month.
For Vafseo patients treated with TIW dosing, Grund said first-refill rates are between 85% and 90%, which he called a significant improvement over once-daily dosing. He said the company’s longer-term goal is to reach a standard refill rate in the 70% to 80% range, though later refill cohorts remain too small for firm conclusions.
Grund also said about 20% of patients who previously discontinued therapy at U.S. Renal Care have restarted Vafseo. He emphasized the need for education across dialysis care teams, saying physicians, anemia managers and clinic staff all need to understand that Vafseo is a titratable drug and that hemoglobin changes may require dose adjustment rather than immediate discontinuation.
Post-TDAPA Access Expected to Expand
Grund said Akebia expects Vafseo pricing to decline after the TDAPA period ends, moving toward “ESA-like pricing.” He said larger dialysis providers are expected to receive lower pricing than smaller providers.
At the same time, he said patient access could expand meaningfully. Grund estimated that about 50% to 60% of patients currently have access through a mix of Medicare Advantage and fee-for-service coverage. After TDAPA, he said, “every single patient has access,” and physicians should no longer need to go through a formulary exception process for many patients.
Grund said Akebia’s broad Vafseo label allows use across eligible dialysis patients. In organizations taking a top-down approach, he said physicians are being asked to consider Vafseo broadly for patients with anemia. In other settings, including DaVita, adoption may begin with patients viewed as most in need, such as those with unstable hemoglobin, high-dose ESA use, hyporesponsiveness or home dialysis patients who may benefit from an oral therapy.
Clinical Data Readouts Could Support Commercial Case
Erik said Akebia continues to generate post-approval data for Vafseo. He highlighted two studies: VOCAL and VOICE.
The VOCAL study is being conducted in DaVita clinics and evaluates TIW Vafseo against standard of care for safety and efficacy. Erik said the study includes a substudy examining red blood cell characteristics, with data expected in the fourth quarter of this year.
The VOICE trial is being conducted with U.S. Renal Care and led by Dr. Geoff Block. Erik said the 2,100-patient study fully enrolled in June and is expected to produce data in the first quarter of 2027. The study is evaluating all-cause mortality and hospitalization rates.
Grund said hospitalization data could be important economically for dialysis organizations. He cited health economic data presented at ADC showing a 7.7% reduction in hospitalization events, a 16% reduction in hospitalization days and estimated annual savings of $3,700 per patient.
Regarding Auryxia, Erik said Akebia generated $180 million in revenue from the product last year. He said the company remains conservative in forecasting Auryxia as generic erosion develops and accounts for those forecasts when budgeting expenses. He also said Akebia does not expect increases in SG&A and views its current infrastructure as highly leverageable.
Pipeline Focuses on Rare Renal and Kidney Injury Programs
Erik said Akebia’s rare renal disease pipeline includes praliciguat, an sGC stimulator being evaluated in a Phase 2 trial for FSGS. The randomized, placebo-controlled, double-blind study is expected to enroll up to 60 patients and will evaluate uPCR levels, with placebo patients crossing over to drug after 24 weeks. He said Akebia would like to see a statistically significant reduction in uPCR versus placebo and a higher proportion of partial and complete responders.
Akebia is also advancing AKB-097, a tissue-targeted complement inhibitor. Erik said the asset is designed to target complement activation locally rather than systemically by binding with high affinity to C3d. The company plans to start a rare renal basket trial in the second half of this year in C3G, lupus nephritis and IgA nephropathy, with data expected in 2027.
A third pipeline program, AKB-9090, uses Akebia’s HIF-PHI technology and is being studied for cardiac surgery-associated acute kidney injury. Erik said a Phase 1 trial is focused on safety, pharmacokinetics and pharmacodynamics, with top-line data expected in the first quarter of next year.
Erik said Akebia has at least two years of cash runway based on its current operating plan. Key upcoming milestones include continued quarterly Vafseo revenue updates, VOCAL data in the fourth quarter, VOICE data in the first quarter of 2027, initiation of the AKB-097 basket trial in the second half of this year and Phase 1 AKB-9090 data in the first quarter of next year.
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.
