secwatch.observer — SEC 8-K summary
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Issuer:     Humacyte, Inc. (HUMA)
CIK:        0001818382
Form:       8-K
Filed at:   2026-06-10T20:34:18+00:00
Accession:  0001104659-26-072382
Event type: other_material
Sentiment:  positive
Materiality: 0.85
Item codes: 8.01, 9.01
LLM model:  deepseek-v4-flash:cloud@v2

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

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1818382/000110465926072382/0001104659-26-072382-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1818382/000110465926072382/tm2617224d1_8k.htm
  HTML page:      https://secwatch.observer/filing/0001104659-26-072382

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