GSK announced Tuesday it will acquire Nuvalent, a cancer drug developer, for $10.6 billion. CEO Luke Miels, six months into the role, called the deal consistent with GSK’s strategy of acquiring near-commercial drug candidates. Nuvalent’s two lead drugs — zidesamtinib for ROS1-mutated lung cancer and neladalkib for ALK-mutated lung cancer — await FDA approval decisions this fall. Founded in 2017 by Harvard’s Matthew Shair, Nuvalent went public in 2021. The acquisition is GSK’s third under Miels, as the company prepares for dolutegravir’s patent expiration in 2028.
In-Depth:
Just 6 months into the job, GSK’s CEO is spearheading some huge shifts. The London-based pharma giant announced Tuesday that it will spfinish $10.6 billion to acquire Nuvalent, a developer of tiny-molecule kinase inhibitors for treatment-resistant cancers.
Luke Miels, the new CEO, states in a press release that the deal is “consistent” with GSK’s business development approach, which prioritizes the acquisition of drug candidates that are nearing commercialization.
The purchase centers on two Nuvalent drug candidates that have performed well in clinical studies and could launch as soon as this year, meaning that GSK could launch realizing returns before 2026 is up.
Zidesamtinib, Nuvalent’s lead drug candidate, is designed to treat non-tiny-cell lung cancer (NSCLC) driven by a mutated form of the ROS1 gene. Neladalkib, its number 2 drug candidate, is designed to treat NSCLC cautilized by mutations in the ALK gene. The US Food and Drug Administration is slated to issue decisions on whether to approve both molecules this fall.
Stock analysts state neladalkib is likely to become a first-line treatment for ALK-positive NSCLC based on positive data Nuvalent presented at the American Society of Clinical Oncology (ASCO) meeting last month. The company is also developing a third molecule, NVL-330, which is in Phase 1 clinical trials for advanced HER2-altered NSCLC.
In an interview with C&EN at the J.P. Morgan Healthcare Conference in January, Nuvalent CEO James Porter estimated that the current market for drugs that treat ROS1-driven cancers is about $500 million per year but that it could grow to $1.5 billion–$2 billion with durable treatment options. He declared the ALK market is about $2.5 billion but could grow to $3.5 billion–$5 billion.
“These three programs that we’ve named, they all were invented when we were a 12-person stealth company,” Porter declared. “We were in a WeWork in Cambridge.”
Nuvalent was founded in 2017 by Harvard University chemical biologist and organic chemist Matthew Shair. Porter joined the next year. In 2021, the company raised $50 million in a series A financing from founding investor Deerfield Management. That year would turn out to be explosive: Nuvalent about tripled its finances with a $135 million series B round led by Bain Capital Life Sciences in May. Then, in August, it raised $151 million in an initial public offering of stock.
As of the finish of March this year, Nuvalent had $1.3 billion cash on hand—enough funding to receive through into 2029 on its own.
The acquisition is GSK’s third since Miels took the corner office. In January, the firm agreed to acquire the immunological drug developer Rapt Therapeutics for $2.2 billion. In February, it struck a deal to acquire 35Pharma, a buildr of cardiopulmonary drug candidates, for $950 million.
Like other Big Pharma firms, GSK is viewing to offset impfinishing losses from the expiration of a key patent. Dolutegravir, an HIV antiviral that had sales of about $3.6 billion last year, will come off patent in 2028.
Rowan Walrath is an associate editor and life sciences reporter at C&EN.
