Celcuity：FDA接受NDA并授予gedatolisib优先审评

FDA已接受gedatolisib的NDA并授予优先审评，PDUFA目标日期为2026年7月17日。该申请涵盖HR+/HER2-晚期乳腺癌的PIK3CA野生型队列的III期VIKTORIA-1研究。这为2026年第三季度潜在获批设定了明确的监管时间表。

关键事实

申报时间: 2026年3月25日 20:10
事件: 申请已受理
方向: 积极
公司: CELCCelcuity
资产: gedatolisib
来源: SEC 8-K
可信度: 有来源
日历: FDA 审批决定 (PDUFA) · 2026年7月17日 · 积极

来源摘录

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