{"schema_version":"secwatch.filing_event.v1","accession":"0001437749-26-014542","form_type":"8-K","ticker":"CLNN","cik":"0001822791","company_name":"Clene Inc.","filed_at":"2026-05-04T23:59:59+00:00","discovered_at":"2026-05-14T18:02:33.013839+00:00","generated_at":"2026-05-15T00:00:18.009718+00:00","sec_items":["7.01","8.01","9.01"],"event_type":"regulatory","sentiment":"positive","materiality_score":0.85,"calibrated_materiality_score":0.85,"confidence":"high","headline":"Clene announces FDA agrees CNM-Au8 data may support accelerated approval NDA for ALS","bullets":["FDA stated proposed data may support NDA submission under accelerated approval pathway for ALS.","FDA acknowledged NfL could potentially serve as a reasonably likely surrogate endpoint to support accelerated approval.","Clene expects to submit NDA for CNM-Au8 in Q3 2026; Phase 3 confirmatory study to start Q1 2027.","NDA supported by NfL and clinical data from Phase 2 trials and NIH-sponsored Expanded Access Protocol.","CNM-Au8 previously received Orphan Drug Designation from FDA for ALS treatment."],"urls":{"canonical":"https://secwatch.observer/filing/0001437749-26-014542","json":"https://secwatch.observer/filing/0001437749-26-014542.json","markdown":"https://secwatch.observer/filing/0001437749-26-014542.md","text":"https://secwatch.observer/filing/0001437749-26-014542.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1822791/000143774926014542/0001437749-26-014542-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1822791/000143774926014542/clnn20260503_8k.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-05-15T00:00:18.009718+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"}