Cogent Biosciences said its experimental kinase inhibitor bezuclastinib achieved every primary and key secondary goal in the registration-directed Part 2 of the Phase 3 SUMMIT study for non-advanced systemic mastocytosis. Patients receiving the drug reported a mean 24-week reduction of 24.3 points in total symptom score, compared with a 15.4-point drop for placebo, delivering an 8.91-point placebo-adjusted benefit (p = 0.0002). The treatment also produced objective biological responses: 87.4% of participants on bezuclastinib registered at least a 50% fall in serum tryptase, a marker of mast-cell burden, versus none in the control arm (p < 0.0001). Safety findings were mainly low-grade and consistent with earlier studies; the most common effects included hair-colour change, altered taste and mild liver-enzyme elevations. Buoyed by the data, Cogent plans to file a U.S. new-drug application for bezuclastinib by the end of 2025 and will present full results at a forthcoming medical meeting. The company reported $237 million in cash and access to a further $350 million through a recently arranged debt facility, which management says should fund the drug’s commercial launch. Cogent shares rose roughly 17% after the announcement, though analysts noted that direct comparisons with Blueprint Medicines’ rival therapy remain unresolved.