Cogent Biosciences reported positive Phase 3 data for bezuclastinib in non-advanced systemic mastocytosis (SM), demonstrating statistically significant improvements in patient-reported symptoms and markers of mast cell burden. Set to potentially rival Blueprint Medicines’ Ayvakit, Cogent plans to submit an NDA to the FDA by year-end. This development follows mid-stage trial success and reinforces bezuclastinib’s potential as a new treatment for this chronic immune disorder.