{"schema_version":"secwatch.filing_event.v1","accession":"0001104659-26-065992","form_type":"8-K","ticker":"OTLK","cik":"0001649989","company_name":"Outlook Therapeutics, Inc.","filed_at":"2026-05-26T11:15:41+00:00","discovered_at":"2026-05-26T11:20:00.210746+00:00","generated_at":"2026-05-26T11:20:07.299444+00:00","sec_items":["8.01","9.01"],"event_type":"regulatory","sentiment":"positive","materiality_score":0.85,"confidence":"high","headline":"FDA grants Outlook Therapeutics appeal; BLA resubmission planned for June 2026","bullets":["FDA concluded substantial evidence of effectiveness for LYTENAVA (bevacizumab-vikg) for nAMD after FDR appeal.","Company will resubmit BLA as Class 1 in June 2026; PDUFA decision expected within 60 days.","Appeal resolves December 30, 2025 Complete Response Letter; FDA directs final labeling discussions.","NORSE TWO trial results plus confirmatory data from NORSE EIGHT and other evidence supported effectiveness."],"urls":{"canonical":"https://secwatch.observer/filing/0001104659-26-065992","json":"https://secwatch.observer/filing/0001104659-26-065992.json","markdown":"https://secwatch.observer/filing/0001104659-26-065992.md","text":"https://secwatch.observer/filing/0001104659-26-065992.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1649989/000110465926065992/0001104659-26-065992-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1649989/000110465926065992/tm2615583d1_8k.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-05-26T11:20:07.299444+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"}