GSK has entered an agreement to acquire Boston-based Nuvalent in a deal valued at $10.6bn (£8.0bn), marking one of the largest acquisitions in the UK pharma group's history.
The transaction centres on three non-small cell lung cancer (NSCLC) assets.
Zidesamtinib (NVL-520) is a next-generation, highly selective ROS1 inhibitor with an FDA target decision date of 18th September 2026, while neladalkib (NVL-655) is a best-in-class ALK inhibitor with a target decision date of 27th November 2026.
Both have received FDA Breakthrough Therapy and Orphan Drug Designations.
A third asset, NVL-330, is a phase I HER2 inhibitor for HER2-altered NSCLC.
All three candidates are designed to address the tolerability limitations and resistance mutations associated with current standard-of-care therapies, including limited central nervous system penetration and limited mutation coverage.
Pivotal data presented at the IASLC 2025 World Conference on Lung Cancer and the 2026 ASCO Annual Meeting supported best-in-class profiles for both lead assets.
ROS1- and ALK-altered NSCLC primarily affects non-smoking adults aged 40-50, a well-defined patient population with significant unmet need.
From a manufacturing and commercialisation standpoint, the deal is structured to accelerate GSK's entry into lung oncology and provide a launch platform for Ris-Rez, its B7-H3 antibody-drug conjugate (ADC) currently in phase III development.
GSK will assume Nuvalent's existing royalty-sharing arrangements, including low-single-digit royalties payable to Royalty Pharma and Deerfield.
Financially, the acquisition is expected to be accretive to core operating profit from 2027 and core EPS from 2029. GSK said in its statement that the firm's existing 2026 full-year guidance on core operating profit and EPS growth remains unchanged.
Closing is expected in Q3 2026, subject to customary regulatory conditions, including HSR Act clearance in the US.