---
schema_version: "secwatch.filing_event.v1"
accession: "0001655759-25-000141"
form_type: "8-K"
ticker: "ARVN"
cik: "0001655759"
company_name: "ARVINAS, INC."
filed_at: "2025-08-08T23:59:59+00:00"
generated_at: "2026-05-17T16:38:16.613778+00:00"
event_type: "regulatory"
sentiment: "positive"
materiality_score: 0.75
calibrated_materiality_score: 0.75
confidence: "high"
source: SEC EDGAR
---

# FDA accepts Arvinas NDA for vepdegestrant in ER+/HER2- advanced breast cancer; PDUFA June 2026

## Summary
- 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.

## SEC filing metadata
- accession: 0001655759-25-000141
- form_type: 8-K
- ticker: ARVN
- cik: 0001655759
- company_name: ARVINAS, INC.
- filed_at: 2025-08-08T23:59:59+00:00
- event_type: regulatory
- sentiment: positive
- materiality_score: 0.75
- calibrated_materiality_score: 0.75
- confidence: high
- sec_items: 7.01, 8.01, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1655759/000165575925000141/0001655759-25-000141-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1655759/000165575925000141/arvn-20250808.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001655759-25-000141
- JSON: https://secwatch.observer/filing/0001655759-25-000141.json
- Plain text: https://secwatch.observer/filing/0001655759-25-000141.txt

This AI-assisted summary is a reading aid. Review the linked SEC EDGAR filing before relying on any specific claim.