Detailed narrative
Vafseo Commercial Momentum
Vafseo achieved significant growth in Q2 FY26, with net product revenue reaching $21.3 million, a 34% sequential increase and 60% year-over-year. The total patient count surpassed 10,500, marking a 41% increase from Q1. This growth was supported by an expanding prescriber base, with approximately one-third of prescribers now outside of USRC, and strong adoption within mid-sized dialysis organizations like USRC, IRC, and DCI. The number of new patient starts was the highest since launch, and about 25% of previously discontinued QD patients are restarting therapy.
VOICE Trial Results
The VOICE trial for Vafseo demonstrated a statistically significant and clinically meaningful reduction in the primary composite endpoint of all-cause mortality and hospitalization, driven by a 10% reduction in hospitalization. The trial, which enrolled 2,116 patients, was stopped early after an interim analysis as of June 1, showing a win odds of 1.16 and a p-value of 0.0016, establishing non-inferiority and superiority. These results are consistent with prior INNO2VATE analysis and are expected to significantly differentiate Vafseo in the market, increasing interest from dialysis providers.
Pipeline Advancement - Ebribafusp
Akebia initiated a Phase II basket trial for ebribafusp (previously AKB-097 and ADX-097), a next-generation complement inhibitor, in IgA nephropathy, lupus nephritis, and C3 glomerulopathy. Ebribafusp is designed for tissue-specific complement inhibition without systemic suppression, potentially offering a safer long-term treatment option. The open-label trial is expected to enroll up to 30 patients, evaluating a once-weekly subcutaneous dose for 26 weeks, with initial data anticipated in 2027. The company also plans to start a Phase II study in ANCA-associated vasculitis next year.
Pipeline Advancement - Praliciguat
The Phase II study for praliciguat in FSGS continues to enroll patients. Praliciguat, a small molecule designed to stimulate the soluble guanylate cyclase enzyme, has shown in animal models to inhibit glomerular scarring and preserve kidney function. The randomized, double-blind, placebo-controlled trial will enroll up to 60 patients with primary or genetic FSGS, with the primary endpoint being change in urine protein creatinine ratio (UPCR) at week 24. Management highlighted the potential for combination therapy with other FSGS treatments due to its unique mechanism of action.
DaVita Engagement and Commercial Strategy
DaVita represents the largest growth opportunity for Vafseo, and while Q3 is not expected to show a meaningful increase, there is heightened senior clinical team engagement regarding operational implementation. This increased interaction, bolstered by the VOICE trial results, is seen as a positive indicator for more impactful growth towards the end of the year and into 2027. Akebia has also implemented a more targeted commercial strategy, prioritizing large group practices and strategic partners to increase the efficiency of its field team.
Financial Overview
Total revenues decreased to $49.1 million in Q2 FY26 from $62.5 million in Q2 FY25, primarily due to a decline in Auryxia revenues ($25.5M vs $47.2M YoY) driven by generic competition and pricing pressure. R&D expenses increased to $14.1 million (from $11M YoY) due to Phase II trials for ebribafusp and praliciguat. SG&A expenses rose to $28.2 million (from $26.6M YoY) due to commercialization activities and a $1.9 million reorganization expense. The company reported a net loss of $8.9 million, compared to net income of $0.2 million in the prior year period. Cash and cash equivalents stood at $155.5 million as of June 30, 2026.