GSK plc
zidesamtinib
non-small cell lung cancer (NSCLC)
Countdown
74days
FDA decision · Sep 18, 2026
What's at stake
The FDA's approval decision on zidesamtinib for non-small cell lung cancer (NSCLC) is due Sep 18, 2026. A green light opens the market; a complete response letter (CRL) usually sinks the stock.
Primary source
· SEC 6-K
verified 10h ago
“Both assets have received FDA Breakthrough Therapy and Orphan Drug Designations * and are in review with target decision dates of 18 September 2026 for zidesamtinib and 27 November 2026 for neladalkib.”