Cogent Biosciences announced positive results from the second part of its Summit Phase II trial of bezuclastinib in non-advanced systemic mastocytosis, meeting primary and key secondary endpoints including symptom improvement and measures of mast cell burden. The data support an imminent NDA submission to the FDA planned for later this year. The drug targets the KIT D816V mutation, offering a potential competitive alternative to Blueprint Medicines’ Ayvakit.