原始来源记录
决策级完整回复函 (CRL)
Incyte：FDA就Zynyz转移性NSCLC sBLA发出CRL
FDA就转移性NSCLC的Zynyz sBLA发出完整回复函，唯一可批准问题为第三方灌装完成设施（Catalent Indiana）的检查发现。CRL未提及对3期POD1UM-304疗效或安全性数据的任何担忧。Incyte正与FDA及Catalent Indiana合作解决相关问题，并支持潜在的重新提交。
关键事实
- 申报时间
- 2026年3月6日 22:03
- 事件
- 完整回复函 (CRL)
- 方向
- 消极
- 来源
- SEC 8-K
- 可信度
- 有来源
来源摘录
incy-20260227 FALSE 0000879169 0000879169 2026-02-27 2026-02-27 UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 8-K CURRENT REPORT Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of Report (Date of earliest event reported): February 27, 2026 INCYTE CORPORATION (Exact name of registrant as specified in its charter) Delaware 001-12400 94-3136539 (State or Other Jurisdiction of Incorporation) (Commission File Number) (I.R.S. Employer Identification No.) 1801 Augustine Cut-Off Wilmington , DE 19803 (Address of principal executive offices) (Zip Code) ( 302 ) 498-6700 (Registrant’s telephone number, including area code) N/A (Former name or former address, if changed since last report.) Check the appropriate box below if the Form 8-K fi