Cogent Biosciences Announces Submission of New Drug Application for Bezuclastinib in Gastrointestinal Stromal Tumors (GIST)
Cogent Biosciences, Inc. (COGT)
Last cogent biosciences, inc. earnings: 11/8 04:05 pm
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Source: GlobeNewswire
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 GISTBezuclastinib 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) -- Cogent Biosciences, Inc. (Nasdaq: COGT), a biotechnology company focused on developing precision therapies for genetically defined diseases, today announced the completion of the submission of its New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for bezuclastinib in patients with Gastrointestinal Stromal Tumors (GIST) who have received prior treatment with imatinib. Based on the positive results from the PEAK trial, the bezuclastinib NDA was submitted under the FDA’s Real-Time Oncology Review (RTOR) program, which is intended to enable a more streamline
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- Cogent Biosciences: Blockbuster Potential, Premium Valuation, Still A 'Buy' [Seeking Alpha]Seeking Alpha
- Cogent Biosciences Announces Submission of New Drug Application for Bezuclastinib in Gastrointestinal Stromal Tumors (GIST) [Yahoo! Finance]Yahoo! Finance
- ???????????(SM)?????2035????13?4000???????????????(CAGR)9%?????? [CNET News]CNET News
- Cogent Biosciences, Cigna Group among top healthcare stocks, according to UBS analysts [Yahoo! Finance]Yahoo! Finance
- A Look At Cogent Biosciences (COGT) Valuation After FDA NDA Acceptance And Shifting Institutional Positions [Yahoo! Finance]Yahoo! Finance
COGT
Sec Filings
- 3/31/26 - Form 144
- 3/31/26 - Form SCHEDULE
- 3/31/26 - Form 4
- COGT's page on the SEC website