GSK agrees to acquire Nuvalent, Inc.

GSK plc, the global biopharma company with a major hub in Philadelphia, announced it has agreed to acquire Boston-based clinical-stage biopharmaceutical company, Nuvalent, Inc.

Nuvalent is focused on creating precisely targeted oncology therapies, and the acquisition is in line with GSK’s strategy of acquiring assets that have validated targets and meaningfully address efficacy and/or tolerability limitations of existing standard-of-care therapies.

The acquisition includes three lung cancer products, including two late-stage, potential best-in-class ROS1 (zidesamtinib) and ALK (neladalkib) inhibitors for non-small cell lung cancer (NSCLC), currently under US FDA review for 2026 approvals. The third asset, NVL-330, is a potential best-in-class HER2 inhibitor currently in phase 1 trials. The acquisition also includes Nuvalent’s preclinical portfolio.

“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,” 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 immediate new sales growth opportunities, officials said, and not only improves profit contributions from 2027, but also provides a platform in lung cancer for rapid expansion.

“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,” James Porter, PhD, CEO of Nuvalent, said. “Our close collaboration with leading physician-scientists and patient advocates has driven remarkable enrollment, accelerating development and building confidence in the clinical profile of these drugs.”