Incyte Corporation
Zynyz
metastatic non-small cell lung cancer
Resolved
130days ago
FDA decision · Feb 27, 2026
What's at stake
An FDA complete response letter on Zynyz for metastatic non-small cell lung cancer is in focus around Feb 27, 2026.
Primary source
· SEC 8-K
verified 16h ago
“On February 27, 2026, the U.S. Food and Drug Administration (“FDA”) issued a Complete Response Letter (“CRL”) for the supplemental Biologics License Application (“sBLA”) for Zynyz® (retifanlimab-dlwr) injection (375mg) for an additional ind”