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Investing.com -- Cogent Biosciences Inc (NASDAQ:COGT) stock surged 8.3% in Monday’s premarket trading after the company announced that the U.S. Food and Drug Administration (FDA) granted Breakthrough Therapy Designation for its bezuclastinib treatment.
The designation was awarded for bezuclastinib in NonAdvanced Systemic Mastocytosis patients previously treated with avapritinib, as well as in patients with Smoldering Systemic Mastocytosis - populations that currently have no approved standard of care.
Breakthrough Therapy Designation is designed to expedite the review of medicines treating serious conditions that show preliminary clinical evidence of substantial improvement over existing therapies. The designation makes Cogent eligible for Priority Review and allows for rolling submission of portions of its application.
"We are excited to announce Breakthrough Therapy Designation for bezuclastinib, which highlights the FDA’s recognition of the unmet need for patients with NonAdvanced Systemtic Mastocytosis and the potential for bezuclastinib to redefine the treatment paradigm for this disease," said Andrew Robbins, Cogent’s President and Chief Executive Officer.
The designation follows positive results from the company’s registration-directed SUMMIT trial, in which bezuclastinib achieved statistical significance across all primary and key secondary endpoints in patients with NonAdvSM. The company announced top-line data in July 2025 and plans to submit its New Drug Application (NDA) for NonAdvSM by the end of 2025.
Cogent Biosciences is focused on developing precision therapies for genetically defined diseases.
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