GSK to acquire Nuvalent for $10.6B, adds two FDA-stage NSCLC inhibitors
- Sponsor
- GSK plc $GSK
GSK announced a $10.6B all-cash agreement to acquire Nuvalent, gaining ROS1 inhibitor zidesamtinib (PDUFA 2026-09-18) and ALK inhibitor neladalkib (PDUFA 2026-11-27). Both NSCLC candidates carry FDA Breakthrough Therapy and Orphan Drug designations.
What this means
Zidesamtinib and neladalkib are experimental lung cancer drugs that target specific genetic mutations found in non-small cell lung cancer (NSCLC). GSK announced plans to acquire Nuvalent, the company developing these drugs, which are currently under FDA review with decisions expected in late 2026. If approved, these treatments could provide new options for NSCLC patients with ROS1 and ALK mutations who have limited existing therapies.
From the source
Zidesamtinib (NVL-520) and neladalkib (NVL-655) are two late-stage, potential best-in-class, next-generation, highly selective ROS1 and ALK inhibitors for treatment of NSCLC. Both assets have received FDA Breakthrough Therapy and Orphan Drug Designations and are in review with target decision dates of 18 September 2026 for zidesamtinib and 27 November 2026 for neladalkib.
Reproduced from SEC EDGAR — 6-K · view original · public domain or open-licensed government work