FDA Grants Breakthrough Therapy Designation to Cogent Biosciences' Bezuclastinib Combination for GIST

Reuters

Jan 26

FDA Grants Breakthrough Therapy Designation to <a href="https://laohu8.com/S/COGT">Cogent Biosciences</a>' Bezuclastinib Combination for GIST

Cogent Biosciences Inc. announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation for bezuclastinib in combination with sunitinib for patients with Gastrointestinal Stromal Tumors (GIST) who have previously been treated with imatinib. The designation is based on results from the PEAK trial, which showed a significant improvement in progression-free survival compared to standard therapy. Additionally, the FDA has agreed to review Cogent’s New Drug Application (NDA) for this combination under the Real-Time Oncology Review (RTOR) program, with Cogent on track to complete the NDA submission in April 2026. No new safety risks were identified in the trial compared to the known profile of sunitinib.

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: 9642124) on January 26, 2026, and is solely responsible for the information contained therein.

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