---
title: "Cogent Biosciences Announces FDA Acceptance of New Drug Application (NDA) with Priority Review for Bezuclastinib in Combination with Sunitinib for Patients with GIST"
type: "News"
locale: "en"
url: "https://longbridge.com/en/news/287917109.md"
description: "The NDA for a new drug has been accepted for review with Priority Review, further highlighting its significance after previously being designated as Breakthrough Therapy and undergoing Real-Time Oncology Review post successful Phase 3 PEAK trials. The PDUFA date has been scheduled for November 30, 2026."
datetime: "2026-05-28T12:02:51.000Z"
locales:
  - [zh-CN](https://longbridge.com/zh-CN/news/287917109.md)
  - [en](https://longbridge.com/en/news/287917109.md)
  - [zh-HK](https://longbridge.com/zh-HK/news/287917109.md)
generator: "portal-rs"
---

# Cogent Biosciences Announces FDA Acceptance of New Drug Application (NDA) with Priority Review for Bezuclastinib in Combination with Sunitinib for Patients with GIST

The NDA for a new drug has been accepted for review with Priority Review, further highlighting its significance after previously being designated as Breakthrough Therapy and undergoing Real-Time Oncology Review post successful Phase 3 PEAK trials. The PDUFA date has been scheduled for November 30, 2026.

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> **Disclaimer: This article is for reference only and does not constitute any investment advice.**