原始出處紀錄
決策級完整回覆函 (CRL)
Incyte：FDA 就 Zynyz 轉移性 NSCLC sBLA 發出 CRL
FDA 針對 Zynyz 轉移性 NSCLC sBLA 發出完整回應函，唯一可批准性問題為第三方灌裝完成設施（Catalent Indiana）的檢查結果。CRL 未提及 Phase 3 POD1UM-304 療效或安全性數據的任何疑慮。Incyte 正與 FDA 及 Catalent Indiana 合作解決問題，並支持潛在的重新提交。
關鍵事實
- 申報時間
- 2026年3月6日 下午10:03
- 事件
- 完整回覆函 (CRL)
- 方向
- 負面
- 來源
- SEC 8-K
- 可信度
- 有出處
來源摘錄
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