Non-small cell lung carcinoma (NSCLC) with EGFR Exon 20 Insertion Mutations
CGEMCullinan ManagementCatalyst overview
Research summary
This catalyst tracks a PDUFA approval decision for Zipalertinib in Non-small cell lung carcinoma (NSCLC) with EGFR Exon 20 Insertion Mutations. The expected timing is based on the latest available company guidance and may change.
REZILIENT1, 2, & 3 trials. 9/14/24- Met primary endpoint. 10/19/25- Presented preliminary data in parallel cohort at ESMO'25. 11/6/25- Type B mtg w/ FDA; REZILIENT3 enrollment in H1 2026. 11/20/25- NDA rolling submission initiated with completion in Q1 2026. 03/10/26:- Rolling NDA for previously treated EGFR ex20ins NSCLC completed in February 2026; next regulatory milestone timing TBA. 04/27/26:- FDA accepted NDA; PDUFA action date February 27, 2027. 05/07/26:- NDA acceptance and February 27, 2027 PDUFA action date for relapsed EGFR ex20ins NSCLC reiterated. 08/06/26:- Zipalertinib NDA accepted; PDUFA date remains February 27, 2027. 08/19/26:- REZILIENT3 interim analysis results selected for WCLC Presidential Symposium on September 14, 2026.
Verification
Confirm timing and program details against the company announcement or filing.