NasdaqGS:CGEMBiotechs
Why Cullinan Therapeutics (CGEM) Is Up 38.1% After FDA Filing for EGFR-mutant Lung Cancer Drug
Taiho Oncology, Taiho Pharmaceutical, and Cullinan Therapeutics recently announced the initiation of a rolling New Drug Application submission to the U.S. FDA for accelerated approval of zipalertinib, targeting EGFR exon 20 insertion-mutated non-small cell lung cancer after chemotherapy.
This milestone builds on zipalertinib’s Breakthrough Therapy Designation and leverages data from the REZILIENT1 Phase 1/2 trial involving previously treated patients.
We'll explore how progress toward FDA...