Nuvalent, Inc. is a clinical-stage biopharmaceutical company headquartered in Cambridge, Massachusetts. Founded in 2017 and listed on Nasdaq under ticker NUVL, it develops precisely targeted small-molecule therapies for cancer using structure-based drug design. Its pipeline focuses on kinase inhibitors for non-small cell lung cancer, including zidesamtinib (ROS1), neladalkib (ALK), and NVL-330 (HER2), along with earlier-stage programs.
In June 2026, GSK agreed to acquire Nuvalent for $10.6 billion in cash, subject to regulatory approvals and tender offer conditions, with expected closing in Q3 2026.
Also known as NUVL and Nuvalent.
Phase I/II ARROS‑1 data show 94% ORR, 90% progression‑free at 12 months and strong intracranial activity; supplemental US submission planned for 2026.
FDA clears zidesamtinib for adults with advanced ROS1‑positive NSCLC after prior ROS1 inhibitor; ARROS‑1 showed 44% ORR and durable responses, including in brain metastases.
Adds three NSCLC assets including two under FDA review for ROS1 and ALK with target decisions later this year; expected 2026 launches; deal valued at ~$10.6bn.
Tender offer launched at $124 per share; requires majority of Class A shares tendered and HSR clearance; no guaranteed delivery; offer set to expire July 14, 2026.
Includes two late-stage ROS1 and ALK NSCLC inhibitors under FDA review for 2026 decisions, plus a HER2 candidate; expected to be accretive to profit from 2027 and funded by debt and cash.
