ESR1-Mutated, ER+/HER2- Advanced or Metastatic Breast Cancer
ARVNArvinas Inc.Catalyst overview
Research summary
This catalyst tracks a Approved update for Vepdegestrant (Mono) in ESR1-Mutated, ER+/HER2- Advanced or Metastatic Breast Cancer. The expected timing is based on the latest available company guidance and may change.
VERITAC-2 trial. 3/11/25- Met primary endpoint. Presented Ph3 data at ASCO'25. 8/8/25- NDA accepted. PDUFA date June 5, 2026. 10/20/25- New patient-reported outcomes data at ESMO'25. 11/24/25- Presentation at SABCS'25 on Dec 12th. 02/24/26:- June 5, 2026 PDUFA date reiterated for ESR1-mutated ER+/HER2- advanced breast cancer indication. 05/01/26:- FDA approved Veppanu for ESR1-mutated ER+/HER2- metastatic breast cancer, ahead of June 5, 2026 PDUFA. 05/12/26:- VEPPANU highlighted as first FDA-approved PROTAC; NCCN breast guidelines Category 2A; global rights licensed to Rigel. 08/04/26:- VEPPANU approval, Rigel license, NCCN Category 2A status reiterated.
Verification
Confirm timing and program details against the company announcement or filing.