Cullinan Therapeutics, Inc. (CGEM) on Tuesday said the U.S. Food and Drug Administration has accepted a New Drug Application for zipalertinib to treat patients with non-small cell lung cancer with EGFR exon 20 insertion mutations.
The FDA set a Prescription Drug User Fee Act target action date of February 27, 2027.
The application is backed by Phase 2b data from the REZILIENT1 trial, where zipalertinib met its primary endpoint by achieving a strong objective response rate in previously treated patients.
Zipalertinib is being developed by Taiho Oncology, Inc., and its parent company, Taiho Pharmaceutical Co., Ltd. globally, and in partnership with Cullinan Therapeutics in the United States.
Cullinan shares gained more than 2% in pre-market trading after closing at $13.25 on Monday.
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