{"filing":{"accession_number":"0001104659-26-065992","cik":"0001649989","ticker":"OTLK","company_name":"Outlook Therapeutics, Inc.","form":"8-K","filing_date":"2026-05-26","report_date":null,"primary_document":"tm2615583d1_8k.htm","primary_document_url":"https://www.sec.gov/Archives/edgar/data/1649989/000110465926065992/tm2615583d1_8k.htm"},"events":[{"id":8952,"run_id":7858,"accession_number":"0001104659-26-065992","anchor_item_number":"8.01","event_type":"other_material","event_domain":"catchall","is_material":true,"confidence":0.75,"summary":"The FDA has granted Outlook's appeal of a Complete Response Letter for its BLA for LYTENAVA™, concluding that substantial evidence of effectiveness has been established and directing the company to work on final labeling for resubmission in June 2026. This is a material regulatory milestone for a biopharmaceutical company's lead product candidate, but it does not fit neatly into the standard taxonomy categories (not an earnings release, not a departure/appointment, not M\u0026A, not a restatement or going-concern issue). The favorable FDA determination materially advances the product toward approval and would significantly affect investor assessment of the company's prospects.","company_name":"Outlook Therapeutics, Inc.","ticker":"OTLK","filing_date":"2026-05-26","form":"8-K","submitted_at":null,"items":[{"id":1414,"accession_number":"0001104659-26-065992","item_number":"8.01","item_title":null,"event_type":"other_material","event_domain":"catchall","is_material":true,"confidence":0.75,"reasoning":"The FDA has granted Outlook's appeal of a Complete Response Letter for its BLA for LYTENAVA™, concluding that substantial evidence of effectiveness has been established and directing the company to work on final labeling for resubmission in June 2026. This is a material regulatory milestone for a biopharmaceutical company's lead product candidate, but it does not fit neatly into the standard taxonomy categories (not an earnings release, not a departure/appointment, not M\u0026A, not a restatement or going-concern issue). The favorable FDA determination materially advances the product toward approval and would significantly affect investor assessment of the company's prospects.","classifier_version":"claude-haiku-4-5-20251001+prompt-9e0ffca5","taxonomy_version":"v1","classified_at":"2026-05-27T02:07:12.299154+00:00","company_name":"","ticker":null,"filing_date":""}]}],"classifications":[{"id":1414,"accession_number":"0001104659-26-065992","item_number":"8.01","item_title":null,"event_type":"other_material","event_domain":"catchall","is_material":true,"confidence":0.75,"reasoning":"The FDA has granted Outlook's appeal of a Complete Response Letter for its BLA for LYTENAVA™, concluding that substantial evidence of effectiveness has been established and directing the company to work on final labeling for resubmission in June 2026. This is a material regulatory milestone for a biopharmaceutical company's lead product candidate, but it does not fit neatly into the standard taxonomy categories (not an earnings release, not a departure/appointment, not M\u0026A, not a restatement or going-concern issue). The favorable FDA determination materially advances the product toward approval and would significantly affect investor assessment of the company's prospects.","classifier_version":"claude-haiku-4-5-20251001+prompt-9e0ffca5","taxonomy_version":"v1","classified_at":"2026-05-27T02:07:12.299154+00:00","company_name":"Outlook Therapeutics, Inc.","ticker":"OTLK","filing_date":"2026-05-26"}]}