{"schema_version":"secwatch.filing_event.v1","accession":"0001437749-26-001049","form_type":"8-K","ticker":"CLNN","cik":"0001822791","company_name":"Clene Inc.","filed_at":"2026-01-12T23:59:59+00:00","discovered_at":"2026-05-14T18:02:36.356138+00:00","generated_at":"2026-05-16T10:56:20.542602+00:00","sec_items":["8.01","9.01"],"event_type":"regulatory","sentiment":"positive","materiality_score":0.75,"calibrated_materiality_score":0.75,"confidence":"high","headline":"Clene reports CNM-Au8 biomarker data supporting potential accelerated approval; FDA meeting in Q1 2026","bullets":["FDA granted in-person Type C meeting in Q1 2026 to discuss CNM-Au8 regulatory path for ALS.","New analyses across ALS cohorts show ~10% NfL reduction associated with 8-13% lower mortality risk.","In HEALEY trial, IGFBP7 responders to CNM-Au8 30mg had 78% mortality risk reduction (HR 0.22, p=0.01).","CNM-Au8 consistently reduced NfL: HEALEY Week 24 GMR 0.905 (p=0.04) and NIH EAP Week 36 AUC diff -0.090 (p=0.037).","Genetic variant linked to lower IGFBP7 expression correlates with ALS reversals, supporting CNM-Au8 mechanism."],"urls":{"canonical":"https://secwatch.observer/filing/0001437749-26-001049","json":"https://secwatch.observer/filing/0001437749-26-001049.json","markdown":"https://secwatch.observer/filing/0001437749-26-001049.md","text":"https://secwatch.observer/filing/0001437749-26-001049.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1822791/000143774926001049/0001437749-26-001049-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1822791/000143774926001049/clnn20260109_8k.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-05-16T10:56:20.542602+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"}