Record mula sa primary source
Decision-gradeComplete response letter
Incyte: Nagbigay ang FDA ng CRL para sa Zynyz sBLA sa metastatic NSCLC
Nagbigay ang FDA ng Complete Response Letter para sa Zynyz sBLA sa metastatic NSCLC, na binanggit ang mga natuklasan sa inspeksyon sa third-party fill-finish facility (Catalent Indiana) bilang tanging isyu sa pag-apruba. Ang CRL ay hindi nagbanggit ng anumang alalahanin tungkol sa Phase 3 POD1UM-304 efficacy o safety data. Ang Incyte ay nakikipagtulungan sa FDA at Catalent Indiana upang matugunan ang mga isyu at suportahan ang potensyal na muling pagsusumite.
Mahahalagang fact
- Na-file
- Mar 6, 2026, 10:03 PM
- Kaganapan
- Complete response letter
- Direksyon
- Negatibo
- Kumpanya
INCYIncyte- Asset
- retifanlimab-dlwr
- Pinagmulan
- SEC 8-K
- Kumpiyansa
- May source
Sipi mula sa source
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