{"schema_version":"secwatch.filing_event.v1","accession":"0001104659-25-028830","form_type":"8-K","ticker":"HUMA","cik":"0001818382","company_name":"Humacyte, Inc.","filed_at":"2025-03-27T23:59:59+00:00","discovered_at":"2026-05-14T18:03:05.040316+00:00","generated_at":"2026-05-24T04:12:35.288977+00:00","sec_items":["7.01","9.01"],"event_type":"regulatory","sentiment":"neutral","materiality_score":0.65,"calibrated_materiality_score":0.65,"confidence":"high","headline":"Humacyte CEO rebuts NYT article questioning FDA approval of Symvess","bullets":["FDA took 19 extra weeks after PDUFA date, consulted three outside surgeons before approving Symvess on Dec 19, 2024.","Dr. Lee, cited as source, resigned from FDA months before approval; his LinkedIn says he 'retired' after a decade.","CEO disputes claim synthetic grafts never rupture; cites MAUDE database showing >25% failures from rupture/death.","In Ukrainian wartime study, all Symvess-treated limbs retained at 30 days with zero infections.","Post-approval study planned to confirm safety; prior studies on 600+ patients never halted for safety."],"urls":{"canonical":"https://secwatch.observer/filing/0001104659-25-028830","json":"https://secwatch.observer/filing/0001104659-25-028830.json","markdown":"https://secwatch.observer/filing/0001104659-25-028830.md","text":"https://secwatch.observer/filing/0001104659-25-028830.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1818382/000110465925028830/0001104659-25-028830-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1818382/000110465925028830/tm2510708d1_8k.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-05-24T04:12:35.288977+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"}