{"schema_version":"secwatch.filing_event.v1","accession":"0001558370-25-004606","form_type":"8-K","ticker":"OTLK","cik":"0001649989","company_name":"Outlook Therapeutics, Inc.","filed_at":"2025-04-08T23:59:59+00:00","discovered_at":"2026-05-14T18:02:49.196862+00:00","generated_at":"2026-05-23T19:03:02.198563+00:00","sec_items":["8.01"],"event_type":"regulatory","sentiment":"neutral","materiality_score":0.6,"confidence":"high","headline":"FDA accepts resubmission of OTLK's BLA for ONS-5010; PDUFA date set for August 27, 2025","bullets":["FDA acknowledged receipt of resubmission of BLA for ONS-5010 (bevacizumab-vikg).","FDA designated the BLA as a Class 2 review with a six-month review period.","PDUFA goal date for the BLA is August 27, 2025."],"urls":{"canonical":"https://secwatch.observer/filing/0001558370-25-004606","json":"https://secwatch.observer/filing/0001558370-25-004606.json","markdown":"https://secwatch.observer/filing/0001558370-25-004606.md","text":"https://secwatch.observer/filing/0001558370-25-004606.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1649989/000155837025004606/0001558370-25-004606-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1649989/000155837025004606/otlk-20250408x8k.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-05-23T19:03:02.198563+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"}