{"filing":{"accession_number":"0001193125-26-304039","cik":"0001579428","ticker":"AXSM","company_name":"Axsome Therapeutics, Inc.","form":"8-K","filing_date":"2026-07-15","report_date":null,"primary_document":"axsm-20260715.htm","primary_document_url":"https://www.sec.gov/Archives/edgar/data/1579428/000119312526304039/axsm-20260715.htm"},"events":[{"id":18010,"run_id":16164,"accession_number":"0001193125-26-304039","anchor_item_number":"8.01","event_type":"operational_other","event_domain":"operational","is_material":true,"confidence":0.75,"summary":"The disclosure announces FDA acceptance of a New Drug Application (NDA) filing for AXS-12 (reboxetine) for cataplexy in narcolepsy, with a PDUFA target action date of May 1, 2027. This is a material regulatory milestone in the drug development process—a critical step toward potential commercialization of a product candidate. While not a final approval, NDA acceptance is a significant operational and strategic event that would affect investor assessment of the company's pipeline progress and commercial prospects. This does not fit the specific categories of earnings release, M\u0026A, impairment, or other named types, making it an operational milestone best classified as operational_other.","company_name":"Axsome Therapeutics, Inc.","ticker":"AXSM","filing_date":"2026-07-15","form":"8-K","submitted_at":null,"items":[{"id":16691,"accession_number":"0001193125-26-304039","item_number":"8.01","item_title":"Other Events.","event_type":"operational_other","event_domain":"operational","is_material":true,"confidence":0.75,"reasoning":"The disclosure announces FDA acceptance of a New Drug Application (NDA) filing for AXS-12 (reboxetine) for cataplexy in narcolepsy, with a PDUFA target action date of May 1, 2027. This is a material regulatory milestone in the drug development process—a critical step toward potential commercialization of a product candidate. While not a final approval, NDA acceptance is a significant operational and strategic event that would affect investor assessment of the company's pipeline progress and commercial prospects. This does not fit the specific categories of earnings release, M\u0026A, impairment, or other named types, making it an operational milestone best classified as operational_other.","classifier_version":"claude-haiku-4-5-20251001+prompt-a85dd512","taxonomy_version":"v1.3","classified_at":"2026-07-15T11:06:39.220536+00:00","company_name":"","ticker":null,"filing_date":""}]}],"classifications":[{"id":16691,"accession_number":"0001193125-26-304039","item_number":"8.01","item_title":"Other Events.","event_type":"operational_other","event_domain":"operational","is_material":true,"confidence":0.75,"reasoning":"The disclosure announces FDA acceptance of a New Drug Application (NDA) filing for AXS-12 (reboxetine) for cataplexy in narcolepsy, with a PDUFA target action date of May 1, 2027. This is a material regulatory milestone in the drug development process—a critical step toward potential commercialization of a product candidate. While not a final approval, NDA acceptance is a significant operational and strategic event that would affect investor assessment of the company's pipeline progress and commercial prospects. This does not fit the specific categories of earnings release, M\u0026A, impairment, or other named types, making it an operational milestone best classified as operational_other.","classifier_version":"claude-haiku-4-5-20251001+prompt-a85dd512","taxonomy_version":"v1.3","classified_at":"2026-07-15T11:06:39.220536+00:00","company_name":"Axsome Therapeutics, Inc.","ticker":"AXSM","filing_date":"2026-07-15"}]}
