Cogent Biosciences reported a second positive pivotal result for its KIT inhibitor bezuclastinib, meeting primary endpoints in a Phase III study of gastrointestinal stromal tumors and earlier data supporting an NDA for non‑advanced systemic mastocytosis. The company said it plans one NDA in the first half of 2026 and another later this year. Investors reacted strongly: shares jumped more than 100% on the Phase III readout and regulatory plans. The firm emphasized robust clinical benefit and tolerability versus standard therapies and signaled discussions with regulators will begin imminently. Analysts flagged market opportunity in imatinib‑resistant GIST and systemic mastocytosis, but noted commercialization will depend on label scope, competitive positioning, and payer access for targeted oncology therapeutics.