{"schema_version":"secwatch.filing_event.v1","accession":"0001104659-24-065609","form_type":"8-K","ticker":"OTLK","cik":"0001649989","company_name":"Outlook Therapeutics, Inc.","filed_at":"2024-05-28T23:59:59+00:00","discovered_at":"2026-05-14T18:03:19.424017+00:00","generated_at":"2026-06-01T08:05:57.283198+00:00","sec_items":["8.01"],"event_type":"regulatory","sentiment":"positive","materiality_score":0.85,"calibrated_materiality_score":0.85,"confidence":"high","headline":"Outlook Therapeutics receives EU marketing authorization for LYTENAVA (bevacizumab gamma) for wet AMD","bullets":["European Commission granted Marketing Authorization for LYTENAVA (bevacizumab gamma) for wet AMD in the EU.","LYTENAVA is the first and only authorized ophthalmic formulation of bevacizumab for wet AMD in the EU.","Approval based on three completed registration trials (NORSE ONE, TWO, THREE) and supporting data.","Marketing authorization applies automatically to all 27 EU member states plus Iceland, Norway, Liechtenstein.","Outlook granted an initial 10 years of market exclusivity in the EU for LYTENAVA."],"urls":{"canonical":"https://secwatch.observer/filing/0001104659-24-065609","json":"https://secwatch.observer/filing/0001104659-24-065609.json","markdown":"https://secwatch.observer/filing/0001104659-24-065609.md","text":"https://secwatch.observer/filing/0001104659-24-065609.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1649989/000110465924065609/0001104659-24-065609-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1649989/000110465924065609/tm2415688d1_8k.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-06-01T08:05:57.283198+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"}