{"schema_version":"secwatch.filing_event.v1","accession":"0001437749-24-024726","form_type":"8-K","ticker":"CLNN","cik":"0001822791","company_name":"Clene Inc.","filed_at":"2024-08-06T23:59:59+00:00","discovered_at":"2026-05-14T18:03:14.682598+00:00","generated_at":"2026-05-31T12:29:36.046366+00:00","sec_items":["7.01","8.01","9.01"],"event_type":"regulatory","sentiment":"positive","materiality_score":0.85,"calibrated_materiality_score":0.85,"confidence":"high","headline":"Clene submits CNM-Au8 data to FDA: 57% survival benefit, 28% NfL reduction in ALS responders","bullets":["CNM-Au8 NfL Responders (nearly half of treated) showed 28% mean NfL reduction vs. increase in non-responders (p<0.00001).","CNM-Au8 30mg in HEALEY trial: 57% decreased mortality risk vs. PRO-ACT controls (HR 0.431, p=0.0002).","CNM-Au8 30mg in RESCUE-ALS: 70% decreased mortality risk vs. PRO-ACT (HR 0.311, p=0.0035).","NfL Responders showed significantly less ALSFRS-R decline at Weeks 64-100 (p<0.01 vs non-responders).","FDA Type C interaction expected Q3 2024 to discuss accelerated approval pathway based on these results."],"urls":{"canonical":"https://secwatch.observer/filing/0001437749-24-024726","json":"https://secwatch.observer/filing/0001437749-24-024726.json","markdown":"https://secwatch.observer/filing/0001437749-24-024726.md","text":"https://secwatch.observer/filing/0001437749-24-024726.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1822791/000143774924024726/0001437749-24-024726-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1822791/000143774924024726/clnn20240805_8k.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-05-31T12:29:36.046366+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"}