Humacyte ATEV meets Phase 3 primary endpoint in female dialysis access; plans supplemental BLA filing H2 2026

Humacyte, Inc.

ATEV patients averaged 220 catheter-free days vs 129 for AV fistula (p=0.00070), meeting superiority endpoint.
Infection rate: 6 per 100 patient-years for ATEV vs 23 for AV fistula; no study access-associated infections in ATEV group.
Trial enrollment will terminate; existing patients followed per protocol. Supplemental BLA targeting FDA filing in second half of 2026.
ATEV observed to have favorable benefit-risk profile with no new safety signals; results to be presented at SVS VAM on June 11.

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