secwatch.observer — SEC 8-K summary
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Issuer:     VERU INC. (VERU)
CIK:        0000863894
Form:       8-K
Filed at:   2023-09-11T23:59:59+00:00
Accession:  0001193125-23-231951
Event type: other_material
Sentiment:  neutral
Materiality: 0.60
Item codes: 8.01
LLM model:  deepseek-v4-flash:cloud@v2

Veru reports Phase 3 ARTEST data: enobosarm monotherapy shows 12.5% ORR vs 0% control in metastatic breast cancer
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- 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.

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/863894/000119312523231951/0001193125-23-231951-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/863894/000119312523231951/d505806d8k.htm
  HTML page:      https://secwatch.observer/filing/0001193125-23-231951

License: Source filings: public domain (SEC EDGAR). Summaries (headline + bullets): CC-BY-4.0; attribute https://secwatch.observer