08:31 AM EST, 11/20/2025 (MT Newswires) -- Cullinan Therapeutics ( CGEM ) , Taiho Pharmaceutical, and its Taiho Oncology subsidiary, said Thursday that they have initiated the rolling submission of a new drug application for zipalertinib to treat patients with locally advanced or metastatic non-small cell lung cancer.

The companies said they expect to complete the NDA submission to the US Food and Drug Administration in Q1 of 2026, with an associated request for priority review.

The filing is supported by the primary efficacy data from a phase 1/2 trial of zipalertinib in NSCLC patients with EGFR exon 20 insertion mutations who have previously received therapy, the companies said.

Zipalertinib is being developed by Taiho Oncology and its parent company Taiho Pharmaceutical in collaboration with Cullinan in the US, the companies said.

Shares of Cullinan were up 2% in recent premarket activity Thursday.