{"schema_version":"secwatch.filing_event.v1","accession":"0001437749-25-021483","form_type":"8-K","ticker":"CLNN","cik":"0001822791","company_name":"Clene Inc.","filed_at":"2025-06-30T23:59:59+00:00","discovered_at":"2026-05-14T18:02:49.937177+00:00","generated_at":"2026-05-18T14:35:42.678821+00:00","sec_items":["8.01","9.01"],"event_type":"regulatory","sentiment":"positive","materiality_score":0.65,"calibrated_materiality_score":0.65,"confidence":"high","headline":"Clene receives constructive FDA feedback on NfL biomarker analysis plan; ALS NDA on track for Q4 2025","bullets":["FDA provided supportive feedback on Clene's statistical analysis plan for neurofilament light (NfL) biomarker analysis from NIH-sponsored Expanded Access Program.","NfL analyses to be conducted early Q4 2025; may support accelerated approval NDA submission for CNM-Au8 in ALS.","Two additional FDA meetings scheduled in Q3 2025: ALS survival data Type C and End-of-Phase 2 MS program Type B.","NDA submission under accelerated approval pathway remains on track for potential submission in Q4 2025.","EAP supports nearly 200 ALS patients treated with compassionate use CNM-Au8; comparator group uses matched controls."],"urls":{"canonical":"https://secwatch.observer/filing/0001437749-25-021483","json":"https://secwatch.observer/filing/0001437749-25-021483.json","markdown":"https://secwatch.observer/filing/0001437749-25-021483.md","text":"https://secwatch.observer/filing/0001437749-25-021483.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1822791/000143774925021483/0001437749-25-021483-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1822791/000143774925021483/clnn20250627_8k.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-05-18T14:35:42.678821+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"}