{"schema_version":"secwatch.filing_event.v1","accession":"0001437749-26-005156","form_type":"8-K","ticker":"CLNN","cik":"0001822791","company_name":"Clene Inc.","filed_at":"2026-02-24T23:59:59+00:00","discovered_at":"2026-05-14T18:02:36.356565+00:00","generated_at":"2026-05-16T00:52:26.807500+00:00","sec_items":["8.01","9.01"],"event_type":"regulatory","sentiment":"positive","materiality_score":0.75,"calibrated_materiality_score":0.75,"confidence":"high","headline":"Clene announces NDA submission for CNM-Au8 planned for Q2 2026; cash runway into Q4 2026","bullets":["Raised over $28M in January 2026 registered direct offering; cash runway into Q4 2026 sufficient through NDA acceptance.","In-person Type C FDA meeting scheduled by end of Q1 2026 to discuss data submitted late 2025.","NDA for CNM-Au8 via accelerated pathway planned for Q2 2026; PDUFA date possible in H2 2026.","Confirmatory Phase 3 RESTORE-ALS trial planned to begin later in 2026 after FDA feedback.","Over 800 patients treated; no CNM-Au8-related SAEs; favorable safety profile across 1,000+ patient-years."],"urls":{"canonical":"https://secwatch.observer/filing/0001437749-26-005156","json":"https://secwatch.observer/filing/0001437749-26-005156.json","markdown":"https://secwatch.observer/filing/0001437749-26-005156.md","text":"https://secwatch.observer/filing/0001437749-26-005156.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1822791/000143774926005156/0001437749-26-005156-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1822791/000143774926005156/clnn20260223_8k.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-05-16T00:52:26.807500+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"}