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BioWorld - Saturday, April 4, 2026
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Home » A second win for Cogent pushes the company toward two NDAs
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A second win for Cogent pushes the company toward two NDAs

Nov. 10, 2025
By Lee Landenberger
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Cogent Biosciences Inc. is now lining up two NDA submissions for its tyrosine kinase inhibitor bezuclastinib in treating two forms of cancer. Cogent intends to submit an NDA for bezuclastinib, a tyrosine kinase inhibitor that targets and inhibits mutated KIT proteins, specifically KIT D816V, in the first half of 2026 to treat gastrointestinal stromal tumors. That will follow the company’s plans for an NDA submission for bezuclastinib in treating non-advanced systemic mastocytosis before the end of 2025.
BioWorld Clinical Cancer Small molecule U.S. NDA

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