GSK has entered an agreement to acquire Nuvalent, a Boston-based, clinical-stage biopharmaceutical company developing precisely targeted oncology therapies, in a transaction valued at $10.6B. The deal aligns with GSK’s strategy of acquiring assets with validated targets that address efficacy and/or tolerability limitations of current standard-of-care treatments and brings three lung cancer products into GSK’s pipeline in a single transaction. The acquisition also includes Nuvalent’s preclinical portfolio of multiple programs built on its precision medicine capabilities and insights from leading physician-scientists.
Nuvalent’s lead assets include zidesamtinib (NVL-520) and neladalkib (NVL-655), two late-stage, potentially best-in-class, next-generation, highly selective ROS1 and ALK inhibitors for non-small cell lung cancer (NSCLC). Both candidates have received FDA Breakthrough Therapy and Orphan Drug Designations and are under review, with target decision dates of September 18, 2026, for zidesamtinib and November 27, 2026, for neladalkib. Subject to FDA approval, the two therapies are expected to launch in 2026 and have multi-blockbuster potential. A third asset, NVL-330, is a potential best-in-class HER2 inhibitor currently in Phase 1 trials for HER2-altered NSCLC.
GSK Chief Executive Officer Luke Miels said the acquisition is a multi-product deal consistent with the company’s focus on clinically proven targets that fill efficacy and tolerability gaps. He noted that the two lead products could launch this year, if approved, offering significant new treatment options for patients with ROS1- and ALK-altered NSCLC. Miels added that the transaction provides GSK with immediate new sales growth opportunities, improving profit contributions from 2027, and establishes a lung cancer platform for rapid expansion alongside Ris-Rez, the company’s B7-H3–targeted antibody-drug conjugate in Phase 3 development.
Pivotal data presented at the IASLC 2025 World Conference on Lung Cancer and the 2026 ASCO Annual Meeting indicate potential best-in-class profiles for zidesamtinib and neladalkib. Both agents are designed to enable longer effective treatment with better quality of life through high target selectivity, durable responses, improved tolerability, enhanced blood-brain barrier penetration for tumor spread, and broad coverage of ALK and ROS1 mutations, potentially overcoming efficacy and tolerability limitations of existing therapies. ROS1- and ALK-altered NSCLC predominantly affect non-smoking adults aged 40–50, a distinct and engaged patient population, and there is already substantive treatment experience with both drugs through clinical development and patient assistance programs.
Nuvalent CEO James Porter said the company has drawn on deep expertise in chemistry and structure-based drug design to assemble a portfolio of novel, potentially best-in-class kinase inhibitors. He credited close collaboration with physician-scientists and patient advocates for accelerating enrollment and building confidence in the clinical profiles of its programs. Porter said GSK’s recognition of the value of Nuvalent’s pipeline and shared vision for practice-changing innovation, together with GSK’s commercial infrastructure and expertise, will support the successful commercialization of zidesamtinib and neladalkib and speed advancement of Nuvalent’s broader discovery pipeline.
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