Humacyte's ATEV Beats AV Fistula in Phase 3 Women's Trial, Supports FDA Label Expansion

Humacyte (HUMA) reported positive interim Phase 3 results for its acellular tissue engineered vessel (ATEV), showing superiority over arteriovenous fistula for hemodialysis access in women with end-stage kidney disease, supporting a planned FDA label expansion for Symvess. In a prespecified analysis of the first 80 patients, ATEV recipients averaged 220.4 catheter-free days in the first 12 months versus 129.3 days for fistula patients (p<0.001). ATEV achieved functional access in a median 1.7 months versus 5.3 months, and dialysis access infections occurred at roughly 6 per 100 patient-years versus 23 for fistulas. Enrollment in the 150-patient V012 trial was stopped after the primary endpoint was met. Combined with two prior Phase 3 trials, the data support a supplemental Biologics License Application targeting submission to the FDA this quarter. ATEV remains investigational for hemodialysis access. The findings were presented at the American Society of Nephrology's Kidney Week 2026 meeting. HUMA traded at $0.41, up 0.31%.