{"schema_version":"secwatch.filing_event.v1","accession":"0001104659-24-123554","form_type":"8-K","ticker":"OTLK","cik":"0001649989","company_name":"Outlook Therapeutics, Inc.","filed_at":"2024-11-27T23:59:59+00:00","discovered_at":"2026-05-14T18:03:09.105444+00:00","generated_at":"2026-05-29T14:34:40.130281+00:00","sec_items":["8.01","9.01"],"event_type":"regulatory","sentiment":"negative","materiality_score":0.85,"calibrated_materiality_score":0.85,"confidence":"high","headline":"Outlook Therapeutics' ONS-5010 misses key endpoint in NORSE EIGHT trial; BLA resubmission planned Q1 2025","bullets":["ONS-5010 did not meet non-inferiority endpoint at week 8 vs ranibizumab (difference -2.257 BCVA letters, margin -3.5).","Mean BCVA improvement: ONS-5010 +4.2 letters, ranibizumab +6.3 letters (p=0.0863).","Favorable safety profile: no retinal vasculitis, ocular AE rates comparable to ranibizumab.","Final month 3 data expected Jan 2025; BLA resubmission to FDA in calendar Q1 2025.","EU/UK marketing authorization already granted; launch in UK and Germany planned for 2025."],"urls":{"canonical":"https://secwatch.observer/filing/0001104659-24-123554","json":"https://secwatch.observer/filing/0001104659-24-123554.json","markdown":"https://secwatch.observer/filing/0001104659-24-123554.md","text":"https://secwatch.observer/filing/0001104659-24-123554.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1649989/000110465924123554/0001104659-24-123554-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1649989/000110465924123554/tm2429443d1_8k.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-05-29T14:34:40.130281+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"}