Humacyte Sets Phase 3 Dialysis Access Presentation Ahead of Planned FDA Filing

Key Points

• Humacyte’s interim Phase 3 V012 results were accepted for a late-breaking oral presentation at ASN Kidney Week 2026.
• The randomized trial compares its acellular tissue engineered vessel, or ATEV, with an arteriovenous fistula in women with end-stage kidney disease.
• Prabir Roy-Chaudhury will present the findings on October 22 in Denver.
• Humacyte plans to submit a supplemental FDA application for hemodialysis access during the fourth quarter of 2026.
• The announcement does not disclose numerical trial results. ATEV remains investigational for dialysis access.

Humacyte (NASDAQ: HUMA) will present interim findings from its Phase 3 V012 trial at ASN Kidney Week, bringing its dialysis-access program before kidney-care specialists ahead of a planned FDA filing. The company intends to use V012 and two previously completed Phase 3 studies to support an application to expand the Symvess label.

V012 Compares Dialysis Access Options in Women

V012 is a randomized controlled trial evaluating Humacyte’s ATEV against an autogenous arteriovenous fistula, or AVF, in female patients with end-stage kidney disease who require hemodialysis access.

Humacyte CEO Laura Niklason said women on dialysis are more likely than men to experience fistula failure and remain dependent on catheters. The study is designed to test whether ATEV can offer a better option for this population.

However, the announcement does not provide patient numbers, efficacy measures or safety findings. Acceptance for a conference presentation does not establish that the trial demonstrated superiority.

Phase 3 Findings Scheduled for October 22 at ASN Kidney Week

Dr. Prabir Roy-Chaudhury of the University of North Carolina at Chapel Hill School of Medicine will present the interim analysis on Thursday, October 22, from 4:40–4:50 p.m. Mountain Time.

The presentation, abstract TH-OR113, is part of the “Late-Breaking Research Orals: Dialysis and Transplantation” session in Four Seasons Ballroom 2 at the Colorado Convention Center. ASN Kidney Week takes place October 21–25 in Denver.

Humacyte Targets Fourth-Quarter FDA Submission

Humacyte said V012, together with two completed Phase 3 hemodialysis-access trials, forms the clinical foundation for its planned supplemental Biologics License Application.

The company is targeting submission this quarter to seek an expansion of the Symvess label to include arteriovenous access for hemodialysis. Symvess is FDA approved for an extremity vascular trauma indication; that approval does not extend to dialysis access.

Investor Takeaway: Data and Filing Are the Next Milestones

For HUMA investors, the October 22 presentation should provide a clearer view of the interim evidence behind the planned label-expansion request. The second milestone is whether Humacyte submits its supplemental application within the stated fourth-quarter window.

The announcement reports presentation acceptance and a filing target—not a new approval or disclosed trial outcome. The strength of the clinical findings and the subsequent FDA review will determine whether the program can advance toward commercial use in dialysis access.