secwatch.observer — SEC 8-K summary
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Issuer:     ARVINAS, INC. (ARVN)
CIK:        0001655759
Form:       8-K
Filed at:   2025-06-06T23:59:59+00:00
Accession:  0001655759-25-000098
Event type: regulatory
Sentiment:  positive
Materiality: 0.85
Item codes: 8.01, 9.01
LLM model:  deepseek-v4-flash:cloud@v2

Arvinas submits NDA to FDA for vepdegestrant in ER+/HER2- ESR1-mutated breast cancer
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- NDA supported by pivotal Phase 3 VERITAC-2 trial results presented at ASCO 2025 and published in NEJM.
- Vepdegestrant is a first-in-class PROTAC ER degrader; fast track designation granted by FDA.
- If approved, vepdegestrant would be first FDA-approved PROTAC ER degrader for advanced breast cancer.
- Jointly developed with Pfizer (PFE); NDA covers ER+/HER2- ESR1-mutated advanced/metastatic breast cancer.
- VERITAC-2 enrolled 624 patients across 25 countries; primary endpoint PFS in ESR1-mutation and ITT populations.

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1655759/000165575925000098/0001655759-25-000098-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1655759/000165575925000098/arvn-20250606.htm
  HTML page:      https://secwatch.observer/filing/0001655759-25-000098

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