Cogent Biosciences announces submission of new drug application for bezuclastinib in advanced systemic mastocytosis

Cogent Biosciences

30 June 2026 - Cogent Biosciences today announced it has submitted its new drug application to the US FDA for bezuclastinib in advanced systemic mastocytosis. 

The submission is based on positive clinical data from the APEX pivotal trial.

Read Cogent Biosciences press release

Michael Wonder

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Michael Wonder

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Medicine , US , Dossier , Registration