{"filing":{"accession_number":"0001104659-26-074346","cik":"0001649989","ticker":"OTLK","company_name":"Outlook Therapeutics, Inc.","form":"8-K","filing_date":"2026-06-16","report_date":null,"primary_document":"tm2618010d1_8k.htm","primary_document_url":"https://www.sec.gov/Archives/edgar/data/1649989/000110465926074346/tm2618010d1_8k.htm"},"events":[{"id":11228,"run_id":9847,"accession_number":"0001104659-26-074346","anchor_item_number":"8.01","event_type":"other_material","event_domain":"catchall","is_material":true,"confidence":0.75,"summary":"The disclosure announces FDA acknowledgment of a BLA resubmission for ONS-5010 (bevacizumab-vikg) with a Class 1 review designation and a 60-day PDUFA goal date of July 29, 2026. This is a material regulatory milestone for a biopharmaceutical company's lead product candidate, but does not fit neatly into the more specific event categories (it is neither a final approval/denial, a going-concern issue, nor a material impairment). The event would affect a reasonable investor's assessment of the company's regulatory progress and near-term catalysts.","company_name":"Outlook Therapeutics, Inc.","ticker":"OTLK","filing_date":"2026-06-16","form":"8-K","submitted_at":null,"items":[{"id":7767,"accession_number":"0001104659-26-074346","item_number":"8.01","item_title":null,"event_type":"other_material","event_domain":"catchall","is_material":true,"confidence":0.75,"reasoning":"The disclosure announces FDA acknowledgment of a BLA resubmission for ONS-5010 (bevacizumab-vikg) with a Class 1 review designation and a 60-day PDUFA goal date of July 29, 2026. This is a material regulatory milestone for a biopharmaceutical company's lead product candidate, but does not fit neatly into the more specific event categories (it is neither a final approval/denial, a going-concern issue, nor a material impairment). The event would affect a reasonable investor's assessment of the company's regulatory progress and near-term catalysts.","classifier_version":"claude-haiku-4-5-20251001+prompt-9e0ffca5","taxonomy_version":"v1","classified_at":"2026-06-16T12:47:06.109881+00:00","company_name":"","ticker":null,"filing_date":""}]}],"classifications":[{"id":7767,"accession_number":"0001104659-26-074346","item_number":"8.01","item_title":null,"event_type":"other_material","event_domain":"catchall","is_material":true,"confidence":0.75,"reasoning":"The disclosure announces FDA acknowledgment of a BLA resubmission for ONS-5010 (bevacizumab-vikg) with a Class 1 review designation and a 60-day PDUFA goal date of July 29, 2026. This is a material regulatory milestone for a biopharmaceutical company's lead product candidate, but does not fit neatly into the more specific event categories (it is neither a final approval/denial, a going-concern issue, nor a material impairment). The event would affect a reasonable investor's assessment of the company's regulatory progress and near-term catalysts.","classifier_version":"claude-haiku-4-5-20251001+prompt-9e0ffca5","taxonomy_version":"v1","classified_at":"2026-06-16T12:47:06.109881+00:00","company_name":"Outlook Therapeutics, Inc.","ticker":"OTLK","filing_date":"2026-06-16"}]}