GSK to buy Nuvalent for $10.6 billion, betting on two investigational lung-cancer drugs awaiting FDA decisions

The all-cash deal hands GSK two investigational, selective inhibitors for genetically defined lung-cancer subsets — zidesamtinib in ROS1-positive NSCLC and neladalkib in ALK-positive NSCLC — both under FDA review, with decisions due this autumn. Neither is approved or available for prescription.

GSK has agreed to acquire Boston-based Nuvalent for $124 a share in cash, an equity value of roughly $10.6 billion, the two companies said on June 9. The deal is structured as an all-cash tender offer for Nuvalent’s Class A and Class B common stock, followed by a second-step merger under Delaware law, with closing expected in the third quarter of 2026. GSK put the price at a 40% premium to Nuvalent’s last closing share price and 26% above its 30-day volume-weighted average; net of cash acquired, GSK valued the transaction at about $9.4 billion.

Not approved, not yet prescribable — and for narrow patient subsets. Both lead assets are investigational and under FDA review; neither is approved or available for prescription, and there is no guarantee either will be cleared. Each is aimed not at lung cancer broadly but at a small, genetically defined subset of non-small-cell lung cancer (NSCLC): zidesamtinib at tumors carrying a ROS1 alteration (ROS1 rearrangements occur in roughly 1–2% of NSCLC) and neladalkib at tumors carrying an ALK alteration (ALK rearrangements in roughly 3–5%). If either is approved, eligibility would be limited to patients whose tumors carry the specific ROS1 or ALK alteration, confirmed by molecular (biomarker) testing; patients with other forms of lung cancer would not be candidates. This is a business and regulatory report, not medical advice — treatment decisions belong with a patient’s oncology team.

The wager rests on two next-generation kinase inhibitors built for these subsets. Both are designed for selectivity — to hit the mutant target while sparing the wild-type protein that drives off-target toxicity — and to stay active in the brain, a common site of metastasis. GSK is also acquiring a third clinical asset, NVL-330 (a HER2 inhibitor in Phase 1), and a preclinical portfolio, though the deal’s value rests on the two lead programs.

Two assets, two looming decisions

The lead asset, zidesamtinib (NVL-520), is an investigational, selective ROS1 inhibitor for ROS1-positive NSCLC, studied in the Phase 1/2 ARROS-1 trial (NCT05118789, sponsored by Nuvalent). Per ClinicalTrials.gov, the Phase 2 portion’s primary endpoint is objective response rate (ORR) assessed by blinded independent central review (BICR); the registry shows no results posted. GSK says the drug is under FDA review with a target decision date of September 18, 2026.

The second, neladalkib (NVL-655), is an investigational, selective ALK inhibitor for ALK-positive NSCLC, evaluated in the Phase 1/2 ALKOVE-1 study (NCT05384626) and now in the first-line Phase 3 ALKAZAR trial (NCT06765109). ALKAZAR is randomizing 450 patients 1:1 (about 225 per arm) against alectinib, with progression-free survival (PFS) by blinded independent central review as the primary endpoint. GSK puts neladalkib’s FDA target decision date at November 27, 2026.

“Today’s acquisition is a multi-product deal,” said GSK chief executive Luke Miels, describing it as “consistent with our approach to acquire assets that have clinically proven targets.”

Neither candidate is approved, and the efficacy data underpinning the filings have not been posted to the trial registry, so no response or survival figures can be independently verified here. On the financial impact, GSK said it expects low-single-digit percentage dilution to core earnings per share in the current year and in 2027 and 2028; it expects the deal to turn accretive to core operating profit in 2027 and to core EPS in 2029.