# Cogent Biosciences Announces FDA Acceptance of New Drug Application (NDA) with Priority Review for Bezuclastinib in Combination with Sunitinib for Patients with GIST
Canonical URL: 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
Ticker: COGT
Company: Cogent Biosciences
Source: Cogent Biosciences
Published: 2026-06-25 13:46 EST
Original Source URL: https://investors.cogentbio.com
## Summary

NDA acceptance with Priority Review builds upon previous assignment of Breakthrough Therapy Designation and Real-Time Oncology Review following Phase 3 PEAK results; PDUFA date set for November 30, 2026 Bezuclastinib combination is first treatment ever to demonstrate statistically significant

## Article Body
NDA acceptance with Priority Review builds upon previous assignment of Breakthrough Therapy Designation and Real-Time Oncology Review following Phase 3 PEAK results; PDUFA date set for November 30, 2026 Bezuclastinib combination is first treatment ever to demonstrate statistically significant
## Recent Company News
- 2026-06-30 12:00 EST — [Cogent Biosciences Announces Submission of New Drug Application (NDA) for Bezuclastinib in Advanced Systemic Mastocytosis (AdvSM)](https://biopharmsignal.com/news/COGT/cogent-biosciences-announces-submission-of-new-drug-application-nda-for-bezuclas-2951df92) — Source: Cogent Biosciences
- 2026-06-25 13:46 EST — [Cogent Biosciences Announces Detailed Data from APEX Pivotal Trial of Bezuclastinib in Patients with Advanced Systemic Mastocytosis at the 2026 European Hematology Association (EHA) Congress](https://biopharmsignal.com/news/COGT/cogent-biosciences-announces-detailed-data-from-apex-pivotal-trial-of-bezuclastinib-in-patients-with-advanced-systemic-mastocytosis-at-the-2026-european-hematology-association-eha-congress) — Source: Cogent Biosciences
- 2026-06-25 13:46 EST — [Cogent Biosciences Announces Preclinical Data from Novel JAK2 V617F Inhibitor at the 2026 European Hematology Association (EHA) Congress](https://biopharmsignal.com/news/COGT/cogent-biosciences-announces-preclinical-data-from-novel-jak2-v617f-inhibitor-at-the-2026-european-hematology-association-eha-congress) — Source: Cogent Biosciences
- 2026-06-25 13:46 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
- 2026-06-25 13:46 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
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