On October 1, 2026, Cullinan Therapeutics announced the initiation of a New Drug Application (NDA) submission to the FDA for zipalertinib in combination with platinum-based chemotherapy for first-line treatment of EGFR exon 20 insertion mutation non-small cell lung cancer. The submission is processed under the Real-Time Oncology Review program, with completion expected by year-end 2026. This action follows positive Phase 3 REZILIENT3 trial results demonstrating improved progression-free survival. Cullinan is eligible for milestone payments of $30 million and up to $100 million from Taiho upon U.S. regulatory approval for second-line and first-line indications, respectively. The company operates in the biopharmaceutical industry, developing T cell engagers for autoimmune diseases and cancer.
