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Cogent Says FDA Accepts NDA for Bezuclastinib Combination

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Cogent Biosciences (COGT) said Thursday the US Food and Drug Administration has accepted its new drug application for bezuclastinib in combination with sunitinib to treat patients with gastrointestinal stromal tumors who have been treated with imatinib previously.

The FDA has granted the application a priority review and assigned a Prescription Drug User Fee Act target action date of Nov. 30, the company said.

The drug regulator has also said there is no plan to hold an advisory committee at this time, Cogent added.

Price: $34.88, Change: $+0.37, Percent Change: +1.07%

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