{"schema_version":"secwatch.filing_event.v1","accession":"0001437749-24-037061","form_type":"8-K","ticker":"CLNN","cik":"0001822791","company_name":"Clene Inc.","filed_at":"2024-12-10T23:59:59+00:00","discovered_at":"2026-05-14T18:03:09.839018+00:00","generated_at":"2026-05-29T05:15:26.067134+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":"FDA provides roadmap for accelerated approval of Clene's CNM-Au8 in ALS via additional NfL biomarker data","bullets":["FDA recommends leveraging additional NfL data from three Expanded Access Protocols and HEALEY trial to support accelerated approval; follow-up meeting early 2025.","Additional NfL biomarker analyses planned to complete Q2 2025; NDA submission targeted mid-2025.","Confirmatory Phase 3 RESTORE-ALS trial to start enrollment before NDA submission, evaluating survival benefit.","Key survival data from November meeting: 78% risk reduction in time to death at Month 12 (HR=0.224, p=0.042).","Over 700 patient-years of CNM-Au8 use with no significant safety concerns; no SAEs related to treatment."],"urls":{"canonical":"https://secwatch.observer/filing/0001437749-24-037061","json":"https://secwatch.observer/filing/0001437749-24-037061.json","markdown":"https://secwatch.observer/filing/0001437749-24-037061.md","text":"https://secwatch.observer/filing/0001437749-24-037061.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1822791/000143774924037061/0001437749-24-037061-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1822791/000143774924037061/clnn20241209_8k.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-05-29T05:15:26.067134+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"}