GSK agreed to acquire Nuvalent in a roughly $10.6 billion deal, adding two late-stage precision oncology drugs under FDA review for non-small cell lung cancer. The assets are led by zidesamtinib (ROS1) and neladalkib (ALK), both of which have received Breakthrough Therapy and Orphan Drug designations. GSK said FDA decision dates are Sept. 18 for zidesamtinib and Nov. 27 for neladalkib. Nuvalent’s approach emphasizes selectivity intended to limit CNS adverse events, with both programs designed to address resistance mechanisms that emerge on current ROS1 and ALK therapies. The transaction also includes NVL-330, a HER2 inhibitor in Phase I testing for HER2-altered NSCLC, plus a preclinical portfolio aimed at filling efficacy and tolerability gaps in targeted oncology. GSK expects the acquisition to create near-term sales growth opportunities and profit contributions starting in 2027, contingent on approvals.