Pharma major GSK has announced a definitive agreement to acquire Nuvalent for approximately USD 10.6 billion in cash (USD 124 per share), a transaction that adds three precision oncology assets targeting driver mutations in non-small cell lung cancer (NSCLC). The lead candidate, zidesamtinib (NVL-520), is a next-generation ROS1 inhibitor with breakthrough therapy designation (BTD) that has already been submitted for approval in the US, with a review deadline date of 18 September 2026. The second asset, neladalkib (NVL-655), is a next-generation ALK inhibitor also granted BTD and submitted for approval in the same market, with a deadline date of 27 November 2026.

Both assets are designed to overcome limitations of current ROS1 and ALK inhibitors, including resistance mutations and central nervous system (CNS) penetration issues. The pipeline also includes NVL-330, a HER2 inhibitor in Phase I for HER2-mutant NSCLC.

According to PharmCube's NextBiopharm® database, this is the largest M&A transaction involving ROS1 or ALK assets. Click here to request a free trial for NextBiopharm®.