{"schema_version":"secwatch.filing_event.v1","accession":"0001193125-23-231951","form_type":"8-K","ticker":"VERU","cik":"0000863894","company_name":"VERU INC.","filed_at":"2023-09-11T23:59:59+00:00","discovered_at":"2026-05-14T18:03:36.816427+00:00","generated_at":"2026-06-10T21:56:45.902522+00:00","sec_items":["8.01"],"event_type":"other_material","sentiment":"neutral","materiality_score":0.6,"calibrated_materiality_score":0.6,"confidence":"high","headline":"Veru reports Phase 3 ARTEST data: enobosarm monotherapy shows 12.5% ORR vs 0% control in metastatic breast cancer","bullets":["Enobosarm monotherapy achieved 2 PR/16 (12.5%) ORR vs 0 PR/18 for active control in discontinued Phase 3 ARTEST trial.","In patients with ≤3 prior endocrine therapies and ≤1 prior CDK4/6 inhibitor, ORR was 33.3% (2/6) vs 0% control.","Enobosarm was well tolerated with no masculinizing AEs or hematocrit increases.","Trial discontinued to focus on earlier-line ENABLAR-2 Phase 3 study of enobosarm + abemaciclib."],"urls":{"canonical":"https://secwatch.observer/filing/0001193125-23-231951","json":"https://secwatch.observer/filing/0001193125-23-231951.json","markdown":"https://secwatch.observer/filing/0001193125-23-231951.md","text":"https://secwatch.observer/filing/0001193125-23-231951.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/863894/000119312523231951/0001193125-23-231951-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/863894/000119312523231951/d505806d8k.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-06-10T21:56:45.902522+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"}