{"schema_version":"secwatch.filing_event.v1","accession":"0001104659-26-074346","form_type":"8-K","ticker":"OTLK","cik":"0001649989","company_name":"Outlook Therapeutics, Inc.","filed_at":"2026-06-16T12:46:01+00:00","discovered_at":"2026-06-16T12:50:00.338703+00:00","generated_at":"2026-06-16T12:50:07.128019+00:00","sec_items":["8.01","9.01"],"event_type":"regulatory","sentiment":"positive","materiality_score":0.8,"calibrated_materiality_score":0.8,"confidence":"high","headline":"FDA accepts resubmitted BLA for Outlook's ONS-5010; PDUFA date July 29, 2026","bullets":["FDA acknowledged receipt of resubmitted BLA for ONS-5010 (bevacizumab-vikg) to treat wet AMD.","Class 1 review with 60-day review period; PDUFA target action date set for July 29, 2026.","If approved, ONS-5010 would be first FDA-approved ophthalmic bevacizumab with standardized manufacturing & labeling.","Company has initiated pre-launch activities in anticipation of potential BLA approval."],"urls":{"canonical":"https://secwatch.observer/filing/0001104659-26-074346","json":"https://secwatch.observer/filing/0001104659-26-074346.json","markdown":"https://secwatch.observer/filing/0001104659-26-074346.md","text":"https://secwatch.observer/filing/0001104659-26-074346.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1649989/000110465926074346/0001104659-26-074346-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1649989/000110465926074346/tm2618010d1_8k.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-06-16T12:50:07.128019+00:00"},"review":{"review_status":"machine_generated","human_reviewed":false,"corrected":false,"correction_note":null,"correction_timestamp":null,"superseded_by":null,"related_filings":[]},"source_grounded_claims":[],"license":"Source filings: public domain (SEC EDGAR). Summaries (headline + bullets): CC-BY-4.0; attribute https://secwatch.observer"}