# Cogent Biosciences Announces FDA Acceptance of New Drug Application for Bezuclastinib in Patients with NonAdvanced Systemic Mastocytosis (NonAdvSM)
Canonical URL: https://biopharmsignal.com/news/COGT/cogent-biosciences-announces-fda-acceptance-of-new-drug-application-for-bezuclastinib-in-patients-with-nonadvanced-systemic-mastocytosis-nonadvsm
Ticker: COGT
Company: Cogent Biosciences
Source: Cogent Biosciences
Published: 2026-03-16 12:00 EST
Original Source URL: https://investors.cogentbio.com
## Summary

NDA based on positive clinical results from the SUMMIT pivotal trial in which bezuclastinib demonstrated clear clinical benefit across all symptom domains WALTHAM, Mass. and BOULDER, Colo., March 16, 2026 (GLOBE NEWSWIRE) -- Cogent Biosciences, Inc.  (Nasdaq: COGT), a biotechnology company focused

## Article Body
NDA based on positive clinical results from the SUMMIT pivotal trial in which bezuclastinib demonstrated clear clinical benefit across all symptom domains WALTHAM, Mass. and BOULDER, Colo., March 16, 2026 (GLOBE NEWSWIRE) -- Cogent Biosciences, Inc.  (Nasdaq: COGT), a biotechnology company focused
## 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
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- 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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