Cogent Biosciences announced positive Phase 3 results for bezuclastinib in imatinib-resistant gastrointestinal stromal tumors (GIST), halving the risk of progression or death versus standard therapy and prompting plans for an NDA submission in the first half of 2026. The company also cleared a Phase II hurdle for systemic mastocytosis and intends to file an NDA this year for that indication. Investors reacted strongly: the company’s shares more than doubled after the announcements. Cogent described bezuclastinib as a KIT D816V–targeting tyrosine kinase inhibitor with potential registrational applicability across multiple rare tumor settings. The twin program strategy aims to establish near-term commercial opportunities and positions Cogent to seek accelerated approvals in niche, high-unmet-need oncology indications.