Akebia Therapeutics, Inc. (AKBA) VOICE Trial Shows Safety Superiority vs ESA

Akebia Therapeutics (AKBA) reported Q3 revenue of $36.9M, down from $58.8M YoY, with a net loss of $14.4M. The company expects Vafseo therapy costs to range between $1,000-$1,500 annually post-TDAPA. AKBA is negotiating contracts and aims for Vafseo to become a standard of care, potentially treating 200,000-250,000 patients. Clinical trials showed Vafseo's active ingredient, vadadustat, reduced hospitalizations by 10% compared to ESAs.

Akebia Therapeutics, Inc. (AKBA) filed an SEC Form 8-K — Results of Operations and Financial Condition. Exhibit 99.1 Akebia Therapeutics Reports Third Quarter 2026 Financial Results and Business Highlights Patients on Vafseo® (vadadustat) increased to approximately 11,500 at the end of Q3 2026 representing an increase of approximately 140% from the end of Q3 2025 Q3 2026 Vafseo® (v

Akebia Therapeutics reported Q3 2026 results, with Vafseo (vadadustat) revenues at $14.8M and 11,500 patients, up 140% YoY. VOCAL trial met non-inferiority endpoint, and VOICE trial showed safety improvements. Auryxia revenues declined due to generic competition. Cash position is $159.3M. AKBA hosts a conference call on Nov 5.

Akebia Therapeutics reported that its VOCAL trial met the primary endpoint, showing non-inferiority of vadadustat to ESA in maintaining hemoglobin levels in chronic kidney disease patients on hemodialysis. The trial enrolled 353 patients, with similar adverse event rates between treatments. Vadadustat is FDA-approved for once-daily use but is being studied for a three-times-weekly dosing regimen.

Akebia Therapeutics (AKBA) announced that vadadustat, its kidney anemia drug, reduced hospitalization rates by 10% compared to standard treatment in dialysis patients, according to the VOICE trial presented at ASN Kidney Week 2026. The trial, sponsored by U.S. Renal Care, showed fewer serious adverse events and better hemoglobin control with vadadustat. Vafseo, the brand name for vadadustat, was approved by the FDA in March 2024 for anemia treatment in dialysis patients.

Akebia Therapeutics (AKBA) dosed the first patient in a Phase 2 trial of ebribafusp for rare kidney diseases. The trial will enroll up to 30 patients and evaluate safety, proteinuria, and kidney function. Ebribafusp aims to inhibit complement activation in kidney tissue. Initial data is expected in 2027. AKBA's stock is currently at $0.90, down 4.87%.