{"schema_version":"secwatch.filing_event.v1","accession":"0001437749-24-029205","form_type":"8-K","ticker":"CLNN","cik":"0001822791","company_name":"Clene Inc.","filed_at":"2024-09-16T23:59:59+00:00","discovered_at":"2026-05-14T18:03:14.683079+00:00","generated_at":"2026-05-31T04:40:22.493287+00:00","sec_items":["8.01","9.01"],"event_type":"regulatory","sentiment":"neutral","materiality_score":0.75,"calibrated_materiality_score":0.75,"confidence":"high","headline":"Clene granted in-person FDA meeting to discuss CNM-Au8 ALS accelerated approval","bullets":["FDA senior leadership meeting will occur before end of November 2024 to review CNM-Au8.","DN1 previously deemed briefing package unsupportive of accelerated approval NDA, but FDA agreed to re-evaluate.","Meeting includes Directors of Office of New Drugs, Office of Neuroscience, DN1, and ALS key opinion leaders.","Over 700 patient-years of safety data with no SAEs attributed to CNM-Au8 by investigators.","Clene believes biomarkers, clinical endpoints, and survival data support CNM-Au8 for ALS."],"urls":{"canonical":"https://secwatch.observer/filing/0001437749-24-029205","json":"https://secwatch.observer/filing/0001437749-24-029205.json","markdown":"https://secwatch.observer/filing/0001437749-24-029205.md","text":"https://secwatch.observer/filing/0001437749-24-029205.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1822791/000143774924029205/0001437749-24-029205-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1822791/000143774924029205/clnn20240912_8k.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-05-31T04:40:22.493287+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"}