1차 출처 기록
결정급PDUFA 날짜 확정
Arvinas: FDA, vepdegestrant NDA에 대해 2026년 6월 5일 PDUFA 설정
FDA가 vepdegestrant의 NDA를 수락하고 2026년 6월 5일을 PDUFA 조치일로 지정했습니다. Arvinas와 Pfizer는 승인 시 출시 잠재력을 극대화하기 위해 제3자 상업 파트너를 공동으로 선정할 예정입니다.
핵심 사실
출처 발췌
EX-99.1 2 q32025earningsrelease.htm EX-99.1 Document Exhibit 99.1 Arvinas Reports Third Quarter 2025 Financial Results and Provides Corporate Update – Presented positive data from Phase 1 clinical trials with ARV-102 in healthy volunteers and patients with Parkinson’s disease – – Presented preclinical data from ARV-806 demonstrating robust and differentiated activity in models of KRAS G12D-mutated cancer – – Presented preclinical data from ARV-027 demonstrating robust degradation of polyQ-AR in muscle, supporting further evaluation as a potentially disease-modifying therapy in SBMA – – Announced agreement with Pfizer to jointly select a third party for the commercialization and potential further development of vepdegestrant – – Company to host conference call today at 8:00 a.m. ET –
