Celcuity：FDA 接受 NDA 並授予 gedatolisib 優先審查資格

FDA 已接受 gedatolisib 的 NDA 並授予優先審查資格，PDUFA 目標日期為 2026 年 7 月 17 日。此申請涵蓋 HR+/HER2- 晚期乳癌的 PIK3CA 野生型群組的 Phase 3 VIKTORIA-1 研究。這為 2026 年第三季潛在核准設定了明確的法規時程。

關鍵事實

申報時間: 2026年3月25日下午08:10
事件: 申請已受理
方向: 正面
公司: CELCCelcuity
資產: gedatolisib
來源: SEC 8-K
可信度: 有出處
行事曆: FDA 審查決定 (PDUFA) · 2026年7月17日 · 正面

來源摘錄

EX-99.1 2 ex99-1.htm EX-99.1 Exhibit 99.1 Celcuity Inc. Reports Release of Fourth Quarter and Full Year 2025 Financial Results and Provides Corporate Update – The U.S. Food and Drug Administration (“FDA”) accepted Celcuity’s New Drug Application (“NDA”) and granted Priority Review with a Prescription Drug User Fee Act (“PDUFA”) goal date of July 17, 2026, for gedatolisib in HR+/HER2-/PIK3CA wild-type (“WT”) advanced breast cancer (“ABC”) – Results from PIK3CA WT cohort of Phase 3 VIKTORIA-1 study of gedatolisib regimens in HR+/HER2- ABC published in Journal of Clinical Oncology – Topline results from the PIK3CA mutant cohort of the Phase 3 VIKTORIA-1 study are expected to be released in the second quarter of 2026 – Management to host webcast and conference call today, March 25, 2026,

SEC 8-K