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Cogent Biosciences Announces Submission of New Drug Application for Bezuclastinib in Gastrointestinal Stromal Tumors (GIST)

Cogent Biosciences (COGT)Cogent BiosciencesFDA / regulatory

Bezuclastinib NDA submitted under the FDA’s RTOR program based on positive results from Phase 3 PEAK trial; bezuclastinib previously granted Breakthrough Therapy Designation in GIST Bezuclastinib combination demonstrated 16.5 month mPFS and 46% ORR in imatinib-resistant GIST patients, dramatically

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Cogent Biosciences

Genetically Defined Diseases Cogent Biosciences develops precision therapies for diseases driven by defined oncogenic mutations. Its portfolio is led by a selective KIT inhibitor and includes earlier programs directed at ErbB2, PI3Kα, KRAS and JAK2. Bezuclastinib Bezuclastinib is designed to inhibit KIT D816V and other exon 17 KIT...

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