{"schema_version":"secwatch.filing_event.v1","accession":"0001104659-25-111316","form_type":"8-K","ticker":"OTLK","cik":"0001649989","company_name":"Outlook Therapeutics, Inc.","filed_at":"2025-11-13T23:59:59+00:00","discovered_at":"2026-05-14T18:02:40.043855+00:00","generated_at":"2026-05-16T20:26:10.125473+00:00","sec_items":["8.01"],"event_type":"regulatory","sentiment":"positive","materiality_score":0.8,"confidence":"high","headline":"FDA accepts Outlook Therapeutics' BLA resubmission for ONS-5010; PDUFA date Dec 31, 2025","bullets":["FDA acknowledged receipt of BLA resubmission for ONS-5010 (bevacizumab-vikg) and assigned Class 1 review.","Class 1 review results in a two-month review period from resubmission date.","PDUFA goal date set for December 31, 2025."],"urls":{"canonical":"https://secwatch.observer/filing/0001104659-25-111316","json":"https://secwatch.observer/filing/0001104659-25-111316.json","markdown":"https://secwatch.observer/filing/0001104659-25-111316.md","text":"https://secwatch.observer/filing/0001104659-25-111316.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1649989/000110465925111316/0001104659-25-111316-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1649989/000110465925111316/tm2531109d1_8k.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-05-16T20:26:10.125473+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"}