{"schema_version":"secwatch.filing_event.v1","accession":"0001104659-26-000066","form_type":"8-K","ticker":"OTLK","cik":"0001649989","company_name":"Outlook Therapeutics, Inc.","filed_at":"2026-01-02T23:59:59+00:00","discovered_at":"2026-05-14T18:02:35.756928+00:00","generated_at":"2026-05-16T11:49:02.874610+00:00","sec_items":["8.01","9.01"],"event_type":"regulatory","sentiment":"negative","materiality_score":0.85,"confidence":"high","headline":"FDA issues Complete Response Letter for Outlook Therapeutics' ONS-5010 BLA for wet AMD","bullets":["FDA CRL states additional mechanistic/natural history data does not alter prior conclusion; confirmatory efficacy evidence needed but not defined.","Outlook Therapeutics disagrees with decision and is exploring all available U.S. approval pathways.","ONS-5010 (LYTENAVA) already approved in EU and UK; commercially available in Germany and UK since June 2025.","CEO Bob Jahr reaffirms commitment to bringing first FDA-approved on-label bevacizumab for wet AMD to U.S. patients.","Company continues to expand European presence and seek commercial partners outside Europe."],"urls":{"canonical":"https://secwatch.observer/filing/0001104659-26-000066","json":"https://secwatch.observer/filing/0001104659-26-000066.json","markdown":"https://secwatch.observer/filing/0001104659-26-000066.md","text":"https://secwatch.observer/filing/0001104659-26-000066.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1649989/000110465926000066/0001104659-26-000066-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1649989/000110465926000066/tm2534608d1_8k.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-05-16T11:49:02.874610+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"}