Exelixis：FDA为zanzalintinib + atezolizumab治疗mCRC设定2026年12月3日PDUFA日期

FDA已受理zanzalintinib联合atezolizumab用于既往治疗的转移性CRC的NDA，并指定PDUFA目标行动日期为2026年12月3日。该申报基于STELLAR-303 III期试验，该试验在ITT人群中达到了双重主要OS终点。

关键事实

申报时间: 2026年8月5日 20:09
事件: PDUFA 日期确定
方向: 中性
公司: EXELExelixis
资产: zanzalintinib
来源: SEC 8-K
可信度: 有来源
日历: FDA 审批决定 (PDUFA) · 2026年12月3日 · 积极

来源摘录

EX-99.1 5 exel20260630exhibit991.htm EX-99.1 Document Exhibit 99.1 Contacts: Chris Senner Chief Financial Officer Exelixis, Inc. 650-837-7240 csenner@exelixis.com Andrew Peters SVP, Strategy & Investor Relations Exelixis, Inc. 650-837-7248 apeters@exelixis.com Exelixis Announces Second Quarter 2026 Financial Results and Provides Corporate Update - Total Revenues of $628.7 million, Cabozantinib Franchise U.S. Net Product Revenues of $573.0 million - - GAAP Diluted EPS of $0.82, Non-GAAP Diluted EPS of $0.91 - - Conference Call and Webcast Today at 5:00 PM ET - ALAMEDA, Calif. – August 5, 2026 - Exelixis, Inc. (Nasdaq: EXEL) today reported financial results for the second quarter of 2026, provided an update on progress toward achieving key corporate objectives, and outlined its commer

SEC 8-K