{"schema_version":"secwatch.filing_event.v1","accession":"0001437749-25-007120","form_type":"8-K","ticker":"CLNN","cik":"0001822791","company_name":"Clene Inc.","filed_at":"2025-03-12T23:59:59+00:00","discovered_at":"2026-05-14T18:03:05.082087+00:00","generated_at":"2026-05-24T22:41:37.999385+00:00","sec_items":["8.01","9.01"],"event_type":"other_material","sentiment":"positive","materiality_score":0.75,"calibrated_materiality_score":0.75,"confidence":"high","headline":"Clene reports CNM-Au8 survival benefit in ALS: median survival up 198 days vs control","bullets":["Median survival 951 days for CNM-Au8 30 mg vs 753 days for Regimen A comparator, a 198-day (6.5-month) gain.","Covariate-adjusted RMST improvement of 124 days (p=0.045); sensitivity analyses including NfL and TRICALS confirm robustness.","In moderate-to-severe ALS (NfL>33, TRICALS -6.5 to -2.5), median survival gain 11.9 months; mortality risk reduced 44% (p=0.006).","RESTORE-ALS-eligible subset: median survival 1079 vs 628 days (451-day gain, 14.8 mo), mortality risk reduced 49% (p=0.006).","Clene to discuss findings with FDA; Phase 3 RESTORE-ALS study launch targeted for mid-2025."],"urls":{"canonical":"https://secwatch.observer/filing/0001437749-25-007120","json":"https://secwatch.observer/filing/0001437749-25-007120.json","markdown":"https://secwatch.observer/filing/0001437749-25-007120.md","text":"https://secwatch.observer/filing/0001437749-25-007120.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1822791/000143774925007120/0001437749-25-007120-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1822791/000143774925007120/clnn20250311_8k.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-05-24T22:41:37.999385+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"}