{"schema_version":"secwatch.filing_event.v1","accession":"0001437749-26-032882","form_type":"8-K","ticker":"CLNN","cik":"0001822791","company_name":"Clene Inc.","filed_at":"2026-10-19T12:05:16+00:00","discovered_at":"2026-10-19T12:10:00.369909+00:00","generated_at":"2026-10-19T12:10:15.183845+00:00","sec_items":["8.01","9.01"],"event_type":"regulatory","sentiment":"positive","materiality_score":0.8,"calibrated_materiality_score":0.8,"confidence":"high","headline":"Clene submits FDA NDA for ALS drug CNM-Au8, seeking accelerated approval","bullets":["NDA submitted to FDA earlier in October 2026 for CNM-Au8 in ALS; Clene publicly announced the submission on October 19, 2026.","Application seeks accelerated approval based on neurofilament light chain biomarker data plus clinical outcomes.","CEO Rob Etherington cited the FDA's \"constructive engagement\" and said Clene will work closely with the agency during review.","Clene says it continues preparations for the confirmatory Phase 3 RESTORE-ALS study while the NDA is pending.","No PDUFA date or filing-acceptance decision disclosed; FDA must accept the application before substantive review begins."],"urls":{"canonical":"https://secwatch.observer/filing/0001437749-26-032882","json":"https://secwatch.observer/filing/0001437749-26-032882.json","markdown":"https://secwatch.observer/filing/0001437749-26-032882.md","text":"https://secwatch.observer/filing/0001437749-26-032882.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1822791/000143774926032882/0001437749-26-032882-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1822791/000143774926032882/clnn20261019_8k.htm"},"model":{"generated_by":"deepseek-v4.1-flash:cloud@v2","generated_at":"2026-10-19T12:10:15.183845+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"}