{"schema_version":"secwatch.filing_event.v1","accession":"0001437749-24-022529","form_type":"8-K","ticker":"CLNN","cik":"0001822791","company_name":"Clene Inc.","filed_at":"2024-07-11T23:59:59+00:00","discovered_at":"2026-05-14T18:03:14.682166+00:00","generated_at":"2026-05-31T21:49:25.017437+00:00","sec_items":["8.01","9.01"],"event_type":"regulatory","sentiment":"neutral","materiality_score":0.7,"calibrated_materiality_score":0.7,"confidence":"high","headline":"Clene to submit FDA briefing book for CNM-Au8 accelerated approval in ALS by July 13","bullets":["Briefing book submission due July 13, 2024, for Type C interaction with FDA in Q3 2024.","New post-hoc analyses include NfL biomarker reduction, survival data, and mechanism-of-action evidence.","Data designed to address prior FDA comments from December 2023 meeting on accelerated approval path.","Clene plans to disclose topline FDA feedback after the Type C interaction concludes."],"urls":{"canonical":"https://secwatch.observer/filing/0001437749-24-022529","json":"https://secwatch.observer/filing/0001437749-24-022529.json","markdown":"https://secwatch.observer/filing/0001437749-24-022529.md","text":"https://secwatch.observer/filing/0001437749-24-022529.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1822791/000143774924022529/0001437749-24-022529-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1822791/000143774924022529/clnn20240711_8k.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-05-31T21:49:25.017437+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"}