{"schema_version":"secwatch.filing_event.v1","accession":"0001437749-25-036712","form_type":"8-K","ticker":"CLNN","cik":"0001822791","company_name":"Clene Inc.","filed_at":"2025-12-03T23:59:59+00:00","discovered_at":"2026-05-14T18:02:40.623423+00:00","generated_at":"2026-05-16T15:25:14.862443+00:00","sec_items":["8.01","9.01"],"event_type":"other_material","sentiment":"positive","materiality_score":0.85,"calibrated_materiality_score":0.85,"confidence":"high","headline":"Clene Announces Statistically Significant ALS Biomarker Results Supporting Accelerated Approval for CNM-Au8","bullets":["FDA-recommended analyses show statistically significant reductions in NfL (p=0.0373) and GFAP (p<0.05) in ALS patients treated with CNM-Au8.","CNM-Au8 treatment associated with 73-77% reduction in risk of death at 1 year in HEALEY ALS Platform Trial open-label extension (p=0.0144).","Company requested Type C meeting with FDA in Q1 2026 for planned NDA submission under accelerated approval pathway.","Placebo participants who switched to CNM-Au8 showed NfL decline or stabilization, consistent with active arm trajectory.","Over 1,000 patient years of exposure data show no drug-related serious adverse events."],"urls":{"canonical":"https://secwatch.observer/filing/0001437749-25-036712","json":"https://secwatch.observer/filing/0001437749-25-036712.json","markdown":"https://secwatch.observer/filing/0001437749-25-036712.md","text":"https://secwatch.observer/filing/0001437749-25-036712.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1822791/000143774925036712/0001437749-25-036712-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1822791/000143774925036712/clnn20251203_8k.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud","generated_at":"2026-05-16T15:25:14.862443+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"}