Cullinan Therapeutics and Partners Begin FDA Rolling Submission for Zipalertinib in EGFR-Mutant NSCLC
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Cullinan Therapeutics Inc., in collaboration with Taiho Oncology and Taiho Pharmaceutical, has started a rolling submission of a New Drug Application (NDA) to the FDA for zipalertinib. The drug targets EGFR-mutant NSCLC and seeks accelerated approval based on positive Phase 1/2 trial results. The submission is expected to be completed in Q1 2026, including a request for priority review.
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