secwatch.observer — SEC 8-K summary
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Issuer:     VERU INC. (VERU)
CIK:        0000863894
Form:       8-K
Filed at:   2026-09-08T12:17:06+00:00
Accession:  0001193125-26-384430
Event type: other_material
Sentiment:  positive
Materiality: 0.75
Item codes: 8.01, 9.01
LLM model:  deepseek-v4-flash:cloud@v2

Veru pivots sabizabulin to daraxonrasib-resistant pancreatic cancer; drops cardiovascular program
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- Sabizabulin showed potent activity (IC50=18.2nM) in daraxonrasib-resistant KRAS pancreatic cancer cells; resistance index 0.25 vs 68 for daraxonrasib.
- Company plans Phase 2b trial in daraxonrasib-resistant metastatic pancreatic cancer; pre-IND meeting with FDA in Q4 2026.
- Veru will no longer explore sabizabulin for atherosclerotic cardiovascular disease inflammation; IP protection until 2043.
- Prior Phase 1b/2 data in 80 prostate cancer patients: median rPFS 11.4 months, ORR 20.7% at 63 mg daily dosing.
- Enobosarm obesity program on track: PLATEAU Phase 2b fully enrolled, interim analysis Q1 2027; Novo Nordisk supply deal.

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/863894/000119312526384430/0001193125-26-384430-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/863894/000119312526384430/d543118d8k.htm
  HTML page:      https://secwatch.observer/filing/0001193125-26-384430

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