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Cogent says FDA accepts bezuclastinib-sunitinib NDA for GIST, grants priority review

PUBT·05/28/2026 12:06:35
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Cogent says FDA accepts bezuclastinib-sunitinib NDA for GIST, grants priority review
  • Cogent Biosciences won FDA acceptance of its NDA for bezuclastinib with sunitinib in GIST previously treated with imatinib.
  • Application received Priority Review. PDUFA target action date set for Nov. 30, 2026.
  • Phase 3 PEAK trial showed median PFS of 16.5 months vs 9.2 months on sunitinib alone.


Disclaimer: This news brief was created by Public Technologies (PUBT) using generative artificial intelligence. While PUBT strives to provide accurate and timely information, this AI-generated content is for informational purposes only and should not be interpreted as financial, investment, or legal advice. Cogent Biosciences Inc. published the original content used to generate this news brief via GlobeNewswire (Ref. ID: 202605280800PRIMZONEFULLFEED9727871) on May 28, 2026, and is solely responsible for the information contained therein.