# Cogent Biosciences Announces Submission of New Drug Application for Bezuclastinib in Gastrointestinal Stromal Tumors (GIST)
Canonical URL: https://biopharmsignal.com/news/COGT/cogent-biosciences-announces-submission-of-new-drug-application-for-bezuclastinib-in-gastrointestinal-stromal-tumors-gist
Ticker: COGT
Company: Cogent Biosciences
Source: Cogent Biosciences
Published: 2026-04-01 12:00 EST
Original Source URL: https://investors.cogentbio.com
## Summary

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

## Article Body
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
## Recent Company News
- 2026-05-30 12:00 EST — [Cogent Biosciences Announces Detailed Clinical Data from PEAK Phase 3 Trial with Bezuclastinib in Combination with Sunitinib in Gastrointestinal Stromal Tumors (GIST) at 2026 American Society of Clinical Oncology (ASCO) Annual Meeting](https://biopharmsignal.com/news/COGT/cogent-biosciences-announces-detailed-clinical-data-from-peak-phase-3-trial-with-bezuclastinib-in-combination-with-sunitinib-in-gastrointestinal-stromal-tumors-gist-at-2026-american-society-of-clinical-oncology-asco-annual-meeting) — Source: Cogent Biosciences
- 2026-05-28 12:00 EST — [Cogent Biosciences Announces FDA Acceptance of New Drug Application (NDA) with Priority Review for Bezuclastinib in Combination with Sunitinib for Patients with GIST](https://biopharmsignal.com/news/COGT/cogent-biosciences-announces-fda-acceptance-of-new-drug-application-nda-with-priority-review-for-bezuclastinib-in-combination-with-sunitinib-for-patients-with-gist) — Source: Cogent Biosciences
- 2026-05-27 12:00 EST — [Cogent Biosciences Announces Participation in the 2026 Jefferies Global Healthcare Conference](https://biopharmsignal.com/news/COGT/cogent-biosciences-announces-participation-in-the-2026-jefferies-global-healthcare-conference) — Source: Cogent Biosciences
- 2026-05-12 13:30 EST — [Cogent Biosciences Announces Multiple Presentations at the European Hematology Association (EHA) 2026 Congress](https://biopharmsignal.com/news/COGT/cogent-biosciences-announces-multiple-presentations-at-the-european-hematology-association-eha-2026-congress) — Source: Cogent Biosciences
- 2026-05-05 12:00 EST — [Cogent Biosciences Reports Recent Business Highlights and First Quarter 2026 Financial Results](https://biopharmsignal.com/news/COGT/cogent-biosciences-reports-recent-business-highlights-and-first-quarter-2026-financial-results) — Source: Cogent Biosciences
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