Primary-source record
Decision-gradeComplete response letter
Incyte: FDA issues CRL for Zynyz sBLA in metastatic NSCLC
FDA issued a Complete Response Letter for the Zynyz sBLA in metastatic NSCLC, citing inspection findings at the third-party fill-finish facility (Catalent Indiana) as the sole approvability issue. The CRL did not cite any concerns with the Phase 3 POD1UM-304 efficacy or safety data. Incyte is working with FDA and Catalent Indiana to address the issues and support a potential resubmission.
Key facts
- Filed
- Mar 6, 2026, 10:03 PM
- Event
- Complete response letter
- Direction
- Negative
- Company
INCYIncyte- Asset
- retifanlimab-dlwr
- Source
- SEC 8-K
- Confidence
- Sourced
Source excerpt
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 filing is intended to simultaneously satisfy the filing obligations of the registrant under any of the following provisions (see General Instruction A.2. below): ☐ Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) ☐ Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) ☐ Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) ☐ Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240-13e-4(c)) Securities registered pursuant to Section 12(b) of the Act: Title of each class Trading Symbol Name of exchange on which registered Common Stock, $