Clinical TrialJun 10, 2026, 04:36 PM
Humacyte's ATEV Trial Meets Primary Endpoint; FDA BLA Planned
AI Summary
Humacyte, Inc. announced positive top-line interim results from its Phase 3 V012 clinical trial for its acellular tissue engineered vessel (ATEV) in arteriovenous access for female patients with end-stage renal disease requiring hemodialysis. The study met its primary endpoint, showing ATEV provided 91 more catheter-free days compared to the standard of care AV fistula, with a statistically significant p-value of 0.00070. Additionally, ATEV patients experienced fewer infections. The company plans to file a supplemental Biologics License Application (BLA) with the FDA in the second half of 2026. Humacyte also made an investor presentation available on the same day.
Key Highlights
- Humacyte's Phase 3 V012 study of ATEV in female dialysis access patients met its primary endpoint.
- ATEV demonstrated 91 more catheter-free days compared to standard AV fistula (p=0.00070).
- ATEV patients experienced 17 fewer dialysis access infections per 100 patient-years compared to AV fistula.
- Humacyte plans to file a supplemental BLA with the FDA in the second half of 2026 for this indication.
- An investor presentation was also made available on June 10, 2026.
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