Cogent Biosciences reported two phase‑trial victories that collectively set up multiple NDA submissions: a Phase III success in imatinib‑resistant gastrointestinal stromal tumors (GIST) and supportive data in systemic mastocytosis. The company said bezuclastinib halved the risk of progression or death versus standard therapy in GIST and plans an NDA in the first half of 2026. Investors reacted strongly, doubling the company’s market value on the news. Cogent’s strategy now centers on parallel regulatory pathways across indications; the near‑term focus is finalizing submission packages and engaging FDA reviewers on trial design and labeling expectations.