{"schema_version":"secwatch.filing_event.v1","accession":"0001437749-26-026653","form_type":"8-K","ticker":"CLNN","cik":"0001822791","company_name":"Clene Inc.","filed_at":"2026-08-10T12:07:37+00:00","discovered_at":"2026-08-10T12:10:05.343156+00:00","generated_at":"2026-08-10T12:10:28.522961+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 reports biomarker analyses showing CNM-Au8 survival benefit in NfL responders for ALS NDA","bullets":["CNM-Au8 30 mg cut death risk 74% at 12 months vs controls in HEALEY (p=0.0124); 38% lower risk over full follow-up (HR 0.621, p=0.037).","Causal analysis: 41% lower death risk in predicted NfL responders (HR 0.593, p=0.026); no benefit in non-responders.","RESCUE-ALS: NfL responders had 76% lower adjusted death risk vs non-responders (HR 0.24, p=0.008); median survival 43.5 vs 19.9 months.","10% NfL decline linked to 6-10% lower death risk in >2,000 untreated ALS patients (APST, ANSWER ALS).","NDA for ALS accelerated approval planned for early Q4 2026; FDA acknowledged NfL as reasonably likely surrogate in March 2026."],"urls":{"canonical":"https://secwatch.observer/filing/0001437749-26-026653","json":"https://secwatch.observer/filing/0001437749-26-026653.json","markdown":"https://secwatch.observer/filing/0001437749-26-026653.md","text":"https://secwatch.observer/filing/0001437749-26-026653.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1822791/000143774926026653/0001437749-26-026653-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1822791/000143774926026653/clnn20260806_8k.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-08-10T12:10:28.522961+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"}