Nuvalent, Inc.
zidesamtinib
ROS1-positive NSCLC
Countdown
74days
FDA decision · Sep 18, 2026
What's at stake
The FDA's approval decision on zidesamtinib for ROS1-positive NSCLC is due Sep 18, 2026. A green light opens the market; a complete response letter (CRL) usually sinks the stock.
Primary source
· SEC 8-K
verified 13h ago
“The New Drug Application (NDA) for zidesamtinib, an investigational ROS1-selective inhibitor, is under review by the U.S. Food and Drug Administration (FDA) ... with a Prescription Drug User Fee Act (PDUFA) target action date of September 1”