- Multi-product oncology deal for assets that have validated targets and aim to address efficacy and/or tolerability limitations of existing therapies
- Includes 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
- Accelerates entry into lung cancer, providing a platform for expansion with Ris-Rez, GSK’s B7-H3 antibody-drug conjugate (ADC)
- Acquisition expected to be accretive to sales and core operating profit in 2027 and core EPS in 2029 inclusive of synergies and reprioritisation
London, UK
GSK plc (LSE/NYSE: GSK) today announced that it has entered an agreement to acquire Nuvalent, Inc. (“Nuvalent”) (NASDAQ: NUVL) a Boston-based clinical-stage biopharmaceutical company focused on creating precisely targeted oncology therapies, for $10.6 billion. The acquisition is consistent 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. It includes three products in lung cancer in a single transaction.
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 programmes, built from their proven precision medicine capabilities and clinical insights from industry-leading physician-scientists.
Luke Miels, Chief Executive Officer, 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.
The acquisition provides GSK with immediate new sales growth opportunities, improving profit contributions from 2027, and a platform in lung cancer for rapid expansion with Ris-Rez, our B7-H3 targeted ADC in phase III 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.1,2 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.3,4
James Porter, PhD, Chief Executive Officer, 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. GSK’s proven track record, infrastructure, and expertise will support the successful commercialisation of zidesamtinib and neladalkib, as well as accelerate advancement of our broader discovery pipeline.”
Financial considerations
Under the terms of the merger agreement, GSK will commence a tender offer to acquire all of Nuvalent’s outstanding shares of Class A and Class B common stock at a purchase price of $124 per share in cash within 10 business days. The aggregate equity value of the transaction is estimated to be $10.6 billion (£8.0 billion). Net of cash acquired, GSK’s aggregate investment is estimated to be $9.4 billion (£7.1 billion). The expected purchase price of $124 per share represents a 40% premium to the last closing price and a 26% premium to the 30 calendar day Volume-Weighted Average Price (VWAP).
There is no change to GSK’s 2026 full-year guidance range of 7-9% core operating profit and core EPS growth. The acquisition is expected to contribute to revenue growth from 2027, be incremental to the Group’s existing ambition for sales of >£40 billion by 2031 and to strengthen core operating profit through the dolutegravir loss of exclusivity period (2028-2030). We expect accretion to core operating profit in 2027 and core EPS in 2029 inclusive of synergies and reprioritisation. Assuming the transaction closes in Q3 2026, we expect low single-digit percentage dilution to core EPS for the current year, FY 2027 and FY 2028.
The transaction will be funded primarily from new and existing debt facilities plus cash, with no impact expected to GSK’s credit rating. GSK will maintain a strong investment grade credit profile and retains balance sheet capacity for further accretive business development.
GSK remains committed to its 70p expected dividend for 2026 and to its progressive dividend policy thereafter.
The transaction is subject to customary closing conditions, including the tender of a majority of Nuvalent’s outstanding shares of Class A common stock in the tender offer and the expiration or termination of the applicable waiting period under the Hart-Scott-Rodino Act in the US. Promptly following the closing of the tender offer, GSK expects to acquire any remaining shares of Nuvalent through a second-step merger under Delaware law at the same price per share.
GSK will account for the transaction as a business combination. GSK will also assume Nuvalent’s existing revenue-sharing arrangements of low-single-digit royalties payable to Royalty Pharma and Deerfield.
Advisors
Leerink Partners LLC and Citigroup Inc. are acting as financial advisors and Davis Polk & Wardwell LLP and Slaughter and May are serving as legal counsel to GSK in connection with the transaction. Centerview Partners LLC is serving as financial advisor and Ropes & Gray LLP is serving as legal counsel to Nuvalent. Jefferies LLC also provided financial advice to Nuvalent. Sidley Austin LLP is corporate counsel to Nuvalent.
