GSK has agreed to acquire Nuvalent in a transaction valued at $10.6 billion, positioning the UK-based pharmaceutical company for its largest acquisition in more than a decade and adding two late-stage lung cancer treatments to its portfolio. Through a tender offer, GSK will seek to purchase Nuvalent shares at $124 each and plans to finance the deal with a combination of cash and debt. The Oncology Acquisition represents a shift from GSK’s recent focus on smaller acquisitions and licensing agreements and stands as the company’s biggest deal since the 2018 purchase of Novartis’ stake in their consumer health joint venture for $13 billion.
According to chief executive Luke Miels, the transaction provides GSK with “immediate new sales growth opportunities” while establishing a stronger position in lung cancer. The acquisition brings in zidesamtinib (NVL-520), a ROS1 inhibitor, and neladalkib (NVL-655), an ALK inhibitor, both currently under FDA review for non-small cell lung cancer (NSCLC), with regulatory decisions expected in September and November, respectively. Zidesamtinib is being reviewed as a treatment for locally advanced or metastatic ROS1-positive NSCLC after prior therapy and could compete with Nuvation’s approved Ibtrozi (taletrectinib). Meanwhile, Nuvalent is pursuing approval for neladalkib in pre-treated advanced ALK-positive NSCLC.
Both drug candidates hold breakthrough therapy designations from the FDA and could reach the market before the end of the year, according to GSK, which believes the medicines have “multi-blockbuster potential.” Beyond those assets, Nuvalent’s pipeline includes NVL-330, a small-molecule HER2 inhibitor currently in phase 1 development for HER2-altered NSCLC. Analysts at Jefferies, cited by the Financial Times, have estimated that Nuvalent’s portfolio could achieve peak annual sales of between $5 billion and $7 billion. The Oncology Acquisition follows GSK’s purchase of food allergy specialist RAPT Therapeutics for up to $2.2 billion and comes after previous cancer-focused deals involving Sierra and IDRx.
Separately, GSK continues to expand its research pipeline through additional partnerships and investments. The company recently entered a $12 billion R&D alliance with Hengrui Pharma covering respiratory, immunology and inflammation, and oncology programmes. In another agreement announced this week, GSK committed £44.5 million to establish a liver fibrosis collaboration with University College London spin-out Engitix, alongside potential milestone payments of up to £118 million. The partnership will use Engitix’s extracellular matrix-based discovery platform to identify mechanisms linked to fibrosis regression and potential therapeutic targets. GSK’s hepatology efforts also include rights to efimosfermin, licensed from Boston Therapeutics last year, and an upcoming FDA decision on chronic hepatitis B candidate bepirovirsen expected in October.
