GSK has agreed to acquire US oncology biotech Nuvalent in a $10.6bn deal, marking its biggest acquisition in more than a decade. Announced on 9 June, the purchase includes two late-stage lung cancer drugs that could receive FDA approval before the end of 2026.
Pipeline candidates
The therapies are both for treating non-small cell lung cancer (NSCLC). The first, zidesamtinib, targets the ROS1 gene that helps control cell growth and division; the second, neladalkib, is an ALK inhibitor. Both are currently under review by the FDA, with decisions expected in September and November, respectively.
The acquisition also includes NVL-330, a HER2 inhibitor currently in phase 1 development, along with several earlier-stage oncology programmes.
A strategic move
The move is the latest step in GSK’s efforts to rebuild its oncology business after selling much of the division to Novartis in 2015. Currently, oncology makes up around 6% of the company’s sales, and GSK believes that this acquisition will strengthen its position in the field, particularly in NSCLC.
Speaking to reporters, Luke Miels, CEO, GSK, who took on the role this year and has overseen three acquisitions so far, described the deal as creating “a platform for rapid expansion in lung cancer”.
The timing is also significant. GSK is facing a major patent cliff, with exclusivity on its HIV drug dolutegravir set to expire between 2028 and 2030. The company expects the Nuvalent acquisition could also offset some of the revenue loss from that expiration.
Analyst reaction
Analysts have responded positively, albeit with some caution.
UBS estimates the two lead assets could generate combined peak sales of $3.75bn. Meanwhile, Emmanuel Papadakis, Analyst, Deutsche Bank, described the assets as offering “relatively derisked and imminent oncology revenue streams”, while noting GSK is paying around three times consensus peak sales estimates for drugs in what he called “familiar if somewhat derivative and crowded” markets.
Nevertheless, according to Reuters, Nuvalent had attracted interest from several large pharmaceutical companies over the past 18 months, reflecting the limited number of late-stage oncology assets nearing approval.
Deal close
The acquisition is expected to close in the third quarter of 2026, subject to regulatory approval. If both lead drugs are approved on schedule, they could reach the market before the end of the year. GSK has said the deal does not affect its financial guidance for 2026.
Featured image: MAXSHOT_PL on Adobe Stock
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