Cogent Biosciences reported Phase 3 success for bezuclastinib in imatinib‑resistant or intolerant gastrointestinal stromal tumors (GIST), showing median progression‑free survival of 16.5 months versus 9.2 months with sunitinib. The company plans an NDA submission in the first half of 2026 and also aims to file an NDA this year based on phase 2 data for non‑advanced systemic mastocytosis. Investors reacted sharply: Cogent’s shares more than doubled after the readout. The data, if sustained through regulatory review, would add a new targeted TKI option for GIST patients and validate the company’s development strategy of filing sequential NDAs across indications.