GSK Agrees to Acquire Nuvalent for $10.6B

Editor’s Take: This deal marks the pharma industry’s second largest acquisition of the year so far as the M&A market continues to move at a rapid pace. Check out Contract Pharma’s Pharmaceutical Industry Mergers & Acquisitions Roundup.

GSK plc has agreed to acquire Nuvalent Inc., a Boston-based clinical-stage biopharmaceutical company focused on creating precisely targeted oncology therapies, for $10.6 billion.

Luke Miels, CEO, GSK, said, “Today’s acquisition is a multi-product deal, consistent with our approach to acquire assets that have clinically proven targets and meaningfully address an efficacy and/or tolerability gap. 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.”

Lung Cancer Products Included in the Acquisition

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 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 I trials for HER2-altered NSCLC. The acquisition also includes Nuvalent’s preclinical portfolio of multiple programs, built from their proven precision medicine capabilities and clinical insights from industry-leading physician-scientists.

James Porter, PhD, CEO, Nuvalent, said, “We’re excited that GSK has recognized the significant value these programs can offer patients and shares our vision for practice-changing innovation. GSK’s proven track record, infrastructure, and expertise will support the successful commercialization of zidesamtinib and neladalkib, as well as accelerate advancement of our broader discovery pipeline.”