secwatch.observer — SEC 8-K summary
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Issuer:     ARVINAS, INC. (ARVN)
CIK:        0001655759
Form:       8-K
Filed at:   2025-08-08T23:59:59+00:00
Accession:  0001655759-25-000141
Event type: regulatory
Sentiment:  positive
Materiality: 0.75
Item codes: 7.01, 8.01, 9.01
LLM model:  deepseek-v4-flash:cloud@v2

FDA accepts Arvinas NDA for vepdegestrant in ER+/HER2- advanced breast cancer; PDUFA June 2026
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- NDA based on Phase 3 VERITAC-2 trial showing statistically significant PFS improvement vs fulvestrant.
- Vepdegestrant is the first PROTAC to demonstrate clinical benefit in breast cancer.
- FDA assigned PDUFA action date of June 5, 2026.
- Jointly developed with Pfizer (NYSE: PFE).
- Target patient population: second-line ESR1-mutant ER+/HER2- advanced/metastatic breast cancer.

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1655759/000165575925000141/0001655759-25-000141-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1655759/000165575925000141/arvn-20250808.htm
  HTML page:      https://secwatch.observer/filing/0001655759-25-000141

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