{"schema_version":"secwatch.filing_event.v1","accession":"0001193125-25-115453","form_type":"8-K","ticker":"VERU","cik":"0000863894","company_name":"VERU INC.","filed_at":"2025-05-08T23:59:59+00:00","discovered_at":"2026-05-14T18:02:51.506588+00:00","generated_at":"2026-05-22T06:13:11.745582+00:00","sec_items":["2.02","9.01"],"event_type":"other_material","sentiment":"positive","materiality_score":0.7,"calibrated_materiality_score":0.7,"confidence":"high","headline":"Veru's enobosarm Phase 2b meets primary endpoint; 71% less lean mass loss with GLP-1","bullets":["Phase 2b QUALITY study met primary endpoint: 71% relative reduction in lean mass loss with enobosarm + semaglutide vs placebo (p=0.002).","Enobosarm 3mg dose resulted in >99% mean relative reduction in lean mass loss (p<0.001); enobosarm 6mg not more effective.","Enobosarm + semaglutide shifted weight loss composition to fat: 90.6% fat loss vs 68% with placebo (p=0.014 for fat mass loss with 6mg).","Physical function improved: 54.4% relative reduction in proportion with ≥10% decline in stair climb power (p=0.0049) for all enobosarm.","Upcoming catalysts: unblinded safety data and Phase 2b extension topline data expected in Q2 2025; End of Phase 2 FDA meeting planned for Q3 2025."],"urls":{"canonical":"https://secwatch.observer/filing/0001193125-25-115453","json":"https://secwatch.observer/filing/0001193125-25-115453.json","markdown":"https://secwatch.observer/filing/0001193125-25-115453.md","text":"https://secwatch.observer/filing/0001193125-25-115453.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/863894/000119312525115453/0001193125-25-115453-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/863894/000119312525115453/d937042d8k.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-05-22T06:13:11.745582+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"}