{"schema_version":"secwatch.filing_event.v1","accession":"0001104659-24-060517","form_type":"8-K","ticker":"OTLK","cik":"0001649989","company_name":"Outlook Therapeutics, Inc.","filed_at":"2024-05-13T23:59:59+00:00","discovered_at":"2026-05-14T18:03:19.423553+00:00","generated_at":"2026-06-02T02:23:40.679239+00:00","sec_items":["8.01","9.01"],"event_type":"regulatory","sentiment":"positive","materiality_score":0.65,"calibrated_materiality_score":0.65,"confidence":"high","headline":"Outlook Therapeutics submits UK MAA for ONS-5010 (bevacizumab gamma) for wet AMD","bullets":["Submitted MAA to UK MHRA via International Recognition Procedure, relying on March 2024 positive CHMP opinion.","ONS-5010 is proposed as the first on-label ophthalmic bevacizumab for wet AMD in the UK.","Clinical program support from three completed registration trials: NORSE ONE, TWO, and THREE.","EU decision on CHMP opinion expected within ~67 days; applies to 27 Member States plus Iceland, Norway, Liechtenstein."],"urls":{"canonical":"https://secwatch.observer/filing/0001104659-24-060517","json":"https://secwatch.observer/filing/0001104659-24-060517.json","markdown":"https://secwatch.observer/filing/0001104659-24-060517.md","text":"https://secwatch.observer/filing/0001104659-24-060517.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1649989/000110465924060517/0001104659-24-060517-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1649989/000110465924060517/tm2414311d1_8k.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-06-02T02:23:40.679239+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"}