Cogent Biosciences (COGT) said Monday that results from its Apex trial evaluating bezuclastinib in patients with advanced systemic mastocytosis showed "rapid and deep clinical benefit."

The company said the drug candidate demonstrated an objective response rate of 57% and 80% per pure pathological response criteria. It added that more than 89% of patients treated with it had a more than a 50% reduction in bone marrow mast cells or clearance of aggregates.

A new drug application to the US Food and Drug Administration for bezuclastinib in advanced systemic mastocytosis will be submitted in H1 2026, the company said.

Cogent also said that based on "positive" results from Apex and its other trials, it is preparing for multiple commercial launches in H2 2026.

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