Cogent Biosciences submits drug application for GIST treatment
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Cogent Biosciences Announces Submission of New Drug Application for Bezuclastinib in Gastrointestinal Stromal Tumors (GIST)
April 1, 2026 8:01 AM EDTBezuclastinib NDA submitted under the FDAs 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 improving upon the current standard of care
WALTHAM, Mass. and BOULDER, Colo., April 01, 2026 (GLOBE NEWSWIRE) --... More
