{"schema_version":"secwatch.filing_event.v1","accession":"0001104659-26-072382","form_type":"8-K","ticker":"HUMA","cik":"0001818382","company_name":"Humacyte, Inc.","filed_at":"2026-06-10T20:34:18+00:00","discovered_at":"2026-06-10T20:36:00.324446+00:00","generated_at":"2026-06-10T20:36:17.493362+00:00","sec_items":["8.01","9.01"],"event_type":"other_material","sentiment":"positive","materiality_score":0.85,"calibrated_materiality_score":0.85,"confidence":"high","headline":"Humacyte ATEV meets Phase 3 primary endpoint in female dialysis access; plans supplemental BLA filing H2 2026","bullets":["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."],"urls":{"canonical":"https://secwatch.observer/filing/0001104659-26-072382","json":"https://secwatch.observer/filing/0001104659-26-072382.json","markdown":"https://secwatch.observer/filing/0001104659-26-072382.md","text":"https://secwatch.observer/filing/0001104659-26-072382.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1818382/000110465926072382/0001104659-26-072382-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1818382/000110465926072382/tm2617224d1_8k.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-06-10T20:36:17.493362+00:00"},"review":{"review_status":"machine_generated","human_reviewed":false,"corrected":false,"correction_note":null,"correction_timestamp":null,"superseded_by":null,"related_filings":[]},"source_grounded_claims":[],"license":"Source filings: public domain (SEC EDGAR). Summaries (headline + bullets): CC-BY-4.0; attribute https://secwatch.observer"}