{"schema_version":"secwatch.filing_event.v1","accession":"0001104659-26-086685","form_type":"8-K","ticker":"OTLK","cik":"0001649989","company_name":"Outlook Therapeutics, Inc.","filed_at":"2026-07-24T21:01:05+00:00","discovered_at":"2026-07-24T21:02:00.296510+00:00","generated_at":"2026-07-24T21:02:05.202523+00:00","sec_items":["8.01","9.01"],"event_type":"regulatory","sentiment":"positive","materiality_score":0.9,"calibrated_materiality_score":0.9,"confidence":"high","headline":"Outlook Therapeutics receives FDA approval for LYTENAVA (bevacizumab-vikg) for wet AMD","bullets":["LYTENAVA is the first and only FDA-approved ophthalmic bevacizumab for wet AMD in the US.","Company anticipates 12 years of Reference Product Exclusivity under the BPCIA.","US anti-VEGF retina market estimated at ~$8.5B annually; commercial launch expected before year-end.","CEO Bob Jahr: approval establishes a new standard for bevacizumab therapy in wet AMD.","LYTENAVA already approved in EU and UK; US approval adds a major market."],"urls":{"canonical":"https://secwatch.observer/filing/0001104659-26-086685","json":"https://secwatch.observer/filing/0001104659-26-086685.json","markdown":"https://secwatch.observer/filing/0001104659-26-086685.md","text":"https://secwatch.observer/filing/0001104659-26-086685.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1649989/000110465926086685/0001104659-26-086685-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1649989/000110465926086685/tm2621316d1_8k.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-07-24T21:02:05.202523+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"}