GSK has agreed to acquire Nuvalent for $10.6bn. Nuvalent is a US-based, clinical-stage biopharmaceutical company focused on creating precisely targeted oncology therapies and the acquisition includes three products in lung cancer, as well as Nuvalent’s preclinical portfolio of multiple programmes.
Zidesamtinib (NVL-520) and neladalkib (NVL-655) are two late-stage, potential best-in-class, next-generation, highly selective ROS1 and ALK inhibitors for treatment of non-small cell lung cancer (NSCLC). Both assets have received FDA Breakthrough Therapy and Orphan Drug Designations and are in review with target decision dates of 18 September 2026 for zidesamtinib and 27 November 2026 for neladalkib.
Subject to FDA approval, they are expected to launch in 2026 and have multi-blockbuster potential. The third asset, NVL-330, is a potential best-in-class HER2 inhibitor currently in phase 1 trials for HER2-altered NSCLC.
Luke Miels, CEO of GSK said: “The two lead products are potential best-in-class assets that could launch this year if approved by the FDA and offer significant new treatment options to patients with two forms of non-small cell lung cancer.
The acquisition provides GSK with…a platform in lung cancer for rapid expansion with Ris-Rez, our B7-H3 targeted ADC in phase 3 clinical development.”
Pivotal data presented at the IASLC 2025 World Conference on Lung Cancer and the 2026 ASCO Annual Meeting show potential best-in-class profiles for zidesamtinib and neladalkib. Both assets aim for longer effective treatment with better quality of life through high target-selectivity, durable treatment response, improved tolerability, enhanced blood-brain barrier penetration for tumour spread, and broader coverage of ALK and ROS1 mutations, potentially addressing efficacy and/or tolerability limitations of existing therapies.
ROS1- and ALK-altered NSCLC primarily affect non-smoking adults aged 40-50, a uniquely defined and engaged patient population. There is substantive treatment experience with zidesamtinib and neladalkib already through their clinical development and patient assistance programmes.
James Porter, CEO of Nuvalent, said: “Since our founding, we have leveraged our deep expertise in chemistry and structure-based drug design to develop a portfolio of novel, potentially best-in-class kinase inhibitors. Our close collaboration with leading physician-scientists and patient advocates has driven remarkable enrolment, accelerating development and building confidence in the clinical profile of these drugs. We’re excited that GSK has recognised the significant value these programmes can offer patients and shares our vision for practice-changing innovation.”