{"filing":{"accession_number":"0001437749-26-026653","cik":"0001822791","ticker":"CLNN","company_name":"Clene Inc.","form":"8-K","filing_date":"2026-08-10","report_date":"2026-08-10","primary_document":"clnn20260806_8k.htm","primary_document_url":"https://www.sec.gov/Archives/edgar/data/1822791/000143774926026653/clnn20260806_8k.htm"},"events":[{"id":26405,"run_id":23996,"accession_number":"0001437749-26-026653","anchor_item_number":"8.01","event_type":"operational_other","event_domain":"operational","is_material":true,"confidence":0.75,"summary":"Clene disclosed new biomarker analyses from Phase 2 ALS trials showing CNM-Au8 efficacy in NfL-responsive patients, with findings to be included in a planned NDA submission for accelerated FDA approval. This represents a material clinical and regulatory milestone for the company's lead therapeutic candidate, directly addressing FDA feedback from a prior Type C meeting.","company_name":"Clene Inc.","ticker":"CLNN","filing_date":"2026-08-10","form":"8-K","submitted_at":null,"items":[{"id":27517,"accession_number":"0001437749-26-026653","item_number":"7.01","item_title":"Regulation FD Disclosure.","event_type":"operational_other","event_domain":"operational","is_material":true,"confidence":0.72,"reasoning":"Clene disclosed new biomarker analyses from Phase 2 ALS trials showing CNM-Au8 efficacy in NfL-responsive patients, which will be included in a planned NDA submission for accelerated FDA approval. This is a material operational/clinical milestone for a late-stage biopharmaceutical company, as it represents significant progress toward regulatory approval of its lead candidate and directly addresses FDA feedback from a March 2026 Type C meeting. While not a traditional earnings release or M\u0026A event, the disclosure of clinical trial results supporting a major regulatory filing is material to investors assessing the company's development pipeline and approval prospects.","classifier_version":"claude-haiku-4-5-20251001+prompt-a85dd512","taxonomy_version":"v1.3","classified_at":"2026-08-10T12:09:53.614546+00:00","company_name":"","ticker":null,"filing_date":""},{"id":27518,"accession_number":"0001437749-26-026653","item_number":"8.01","item_title":"Other Events.","event_type":"operational_other","event_domain":"operational","is_material":true,"confidence":0.75,"reasoning":"Clene announced biomarker analyses from Phase 2 ALS trials showing NfL response correlates with clinical benefit in CNM-Au8-treated patients. These findings will be included in the company's planned NDA submission seeking accelerated FDA approval. This is a material operational/clinical milestone disclosing progress toward regulatory approval of a lead therapeutic candidate, but does not fit the specific categories of earnings release, M\u0026A, impairment, or other named event types. The disclosure is clearly material to investors assessing the company's clinical development trajectory and regulatory prospects.","classifier_version":"claude-haiku-4-5-20251001+prompt-a85dd512","taxonomy_version":"v1.3","classified_at":"2026-08-10T12:09:53.614546+00:00","company_name":"","ticker":null,"filing_date":""}]}],"classifications":[{"id":27517,"accession_number":"0001437749-26-026653","item_number":"7.01","item_title":"Regulation FD Disclosure.","event_type":"operational_other","event_domain":"operational","is_material":true,"confidence":0.72,"reasoning":"Clene disclosed new biomarker analyses from Phase 2 ALS trials showing CNM-Au8 efficacy in NfL-responsive patients, which will be included in a planned NDA submission for accelerated FDA approval. 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