Cogent Biosciences revealed positive top-line results from a Phase II registration-directed trial of bezuclastinib in indolent systemic mastocytosis, a rare immune disorder. The drug demonstrated statistically significant and clinically meaningful improvements in symptoms, patient-reported outcomes, and mast cell burden. Shares surged following the announcement, and Cogent is targeting an NDA submission by year-end. This reinforces bezuclastinib’s potential as a new therapeutic option for patients with systemic mastocytosis, addressing an unmet medical need.