Arvinas: vepdegestrant NDA PDUFA ditetapkan pada 5 Juni 2026

FDA telah menetapkan tanggal aksi PDUFA pada 5 Juni 2026 untuk NDA vepdegestrant sebagai monoterapi pada kanker payudara lanjut atau metastatik ER+/HER2- dengan mutasi ESR1. Arvinas dan Pfizer telah sepakat untuk mengalihkan hak komersialisasi kepada pihak ketiga daripada melakukan komersialisasi bersama.

Fakta utama

Diajukan: 17 Sep 2025, 20.32
Peristiwa: Tanggal PDUFA ditetapkan
Arah: Netral
Perusahaan: ARVNArvinas
Aset: vepdegestrant
Sumber: SEC 8-K
Keyakinan: Bersumber
Kalender: Keputusan FDA (PDUFA) · 5 Jun 2026 · Disetujui

Kutipan sumber

EX-99.1 2 arvnstrategicupdaterelea.htm EX-99.1 arvnstrategicupdaterelea Exhibit 99.1 Arvinas Provides Update on Collaboration with Pfizer and Announces Further Actions to Support Value Creation Arvinas and Pfizer plan to jointly select third party for the out-licensing and commercialization of vepdegestrant Additional cost optimization measures expected to realize total annual savings of more than $100 million compared to FY 2024 Board authorizes stock repurchase program of up to $100 million Reaffirms cash runway guidance through the second half of 2028 NEW HAVEN, Conn., Sept. 17, 2025 – Arvinas, Inc. (Nasdaq: ARVN) today provided an update on its collaboration with Pfizer Inc. (NYSE: PFE) for the co-development of vepdegestrant, an investigational oral PROTAC (PROteolysis TArgeting Chi

SEC 8-K