{"filing":{"accession_number":"0001437749-26-032882","cik":"0001822791","ticker":"CLNN","company_name":"Clene Inc.","form":"8-K","filing_date":"2026-10-19","report_date":"2026-10-19","primary_document":"clnn20261019_8k.htm","primary_document_url":"https://www.sec.gov/Archives/edgar/data/1822791/000143774926032882/clnn20261019_8k.htm"},"events":[{"id":35961,"run_id":33150,"accession_number":"0001437749-26-032882","anchor_item_number":"8.01","event_type":"operational_other","event_domain":"operational","is_material":true,"confidence":0.85,"summary":"Clene announced submission of a New Drug Application (NDA) to the FDA for CNM-Au8 seeking accelerated approval for ALS treatment. This is a material regulatory milestone in the drug development process—a critical step toward potential commercialization of the company's lead candidate. While not fitting a specific named event type, this is clearly an operational/strategic business event that would affect a reasonable investor's assessment of the company's progress and prospects.","company_name":"Clene Inc.","ticker":"CLNN","filing_date":"2026-10-19","form":"8-K","submitted_at":null,"items":[{"id":40201,"accession_number":"0001437749-26-032882","item_number":"8.01","item_title":"Other Events.","event_type":"operational_other","event_domain":"operational","is_material":true,"confidence":0.85,"reasoning":"Clene announced submission of a New Drug Application (NDA) to the FDA for CNM-Au8 seeking accelerated approval for ALS treatment. This is a material regulatory milestone in the drug development process—a critical step toward potential commercialization of the company's lead candidate. While not fitting a specific named event type, this is clearly an operational/strategic business event that would affect a reasonable investor's assessment of the company's progress and prospects.","classifier_version":"claude-haiku-4-5-20251001+prompt-a85dd512","taxonomy_version":"v1.3","classified_at":"2026-10-19T12:06:41.746767+00:00","company_name":"","ticker":null,"filing_date":""}]}],"classifications":[{"id":40201,"accession_number":"0001437749-26-032882","item_number":"8.01","item_title":"Other Events.","event_type":"operational_other","event_domain":"operational","is_material":true,"confidence":0.85,"reasoning":"Clene announced submission of a New Drug Application (NDA) to the FDA for CNM-Au8 seeking accelerated approval for ALS treatment. This is a material regulatory milestone in the drug development process—a critical step toward potential commercialization of the company's lead candidate. While not fitting a specific named event type, this is clearly an operational/strategic business event that would affect a reasonable investor's assessment of the company's progress and prospects.","classifier_version":"claude-haiku-4-5-20251001+prompt-a85dd512","taxonomy_version":"v1.3","classified_at":"2026-10-19T12:06:41.746767+00:00","company_name":"Clene Inc.","ticker":"CLNN","filing_date":"2026-10-19"}]}