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Nuvalent's cancer drug under FDA review, weeks after GSK closes $10.6B buyout

on July 23, 2026

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GSK has agreed to acquire Nuvalent, Inc. for $10.6 billion, adding two late-stage lung cancer drug candidates—zidesamtinib (a ROS1 inhibitor) and neladalkib (an ALK inhibitor)—both of which are under FDA review for advanced non‑small cell lung cancer (NSCLC).

The FDA has set target decision dates of September 18, 2026 for zidesamtinib and November 27, 2026 for neladalkib; if approved, GSK plans to launch the drugs in 2026, calling them potential multi‑blockbusters.

The Nuvalent buyout, announced on June 9, 2026, is GSK’s largest acquisition in over a decade and is expected to close in the third quarter of 2026, financed through a mix of cash and debt.

Sources:

GSK enters agreement to acquire Nuvalent, Inc.

Nuvalent Announces FDA Acceptance of New Drug Application for Zidesamtinib for the Treatment of TKI Pre-treated Patients with Advanced ROS1-positive NSCLC

FDA accepts Nuvalent's NDA for ROS1-positive NSCLC treatment

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ALK gene Antineoplastic Agents Approved neladalkib Non-Small Cell Lung Carcinoma Nuvalent ROS1 gene SmithKline Beecham United States Food and Drug Administration zidesamtinib

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