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Cogent Biosciences to Initiate New Drug Application (NDA) Submission for Bezuclastinib Under Real-Time Oncology Review (RTOR)

Cogent Biosciences (COGT)Cogent BiosciencesClinical readout

- PEAK trial first ever study to demonstrate statistical significance over an active comparator in GIST patients, with bezuclastinib plus sunitinib combination demonstrating mPFS of 16.5 months and ORR of 46% in patients who had received prior treatment with imatinib - Cogent is expected

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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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