GlaxoSmithKline agreed to acquire Nuvalent for $10.6 billion in cash, aiming to strengthen its lung cancer pipeline with two programs currently under FDA review. The deal adds ROS1 inhibitor zidesamtinib (NVL-520) and ALK inhibitor eladalkib (NVL-655), both granted Breakthrough Therapy and Orphan Drug designations. The FDA has set target decision dates of September 18 for zidesamtinib and November 27 for neladalkib, with both drugs designed for selectivity intended to improve CNS tolerability. Nuvalent’s third NSCLC asset, NVL-330, is also included and is in early-stage study. GSK characterized the acquisition as a multi-product bet on assets with clinically proven targets and a gap in efficacy and/or tolerability. CEO Luke Miels said the two lead therapies could launch this year if approved, expanding treatment options for ROS1- and ALK-driven NSCLC. For Nuvalent, the transaction is the next step toward commercialization of its solvant-front resistance addressing concepts—while for GSK it’s a bet that near-term regulatory milestones can translate into durable growth in lung oncology.