FDA approves Nuvalent's cancer drug, a week after GSK closed $10.6B buyout
FDA approves Nuvalent's cancer drug, a week after GSK closed $10.6B buyout.
Nuvalent
Nuvalent is a clinical-stage biopharmaceutical company developing small-molecule kinase inhibitors for oncology, with a particular focus on designing brain-penetrant, resistance-selective compounds. Its lead programs target ROS1 and ALK in non-small cell lung cancer, with additional programs in HER2 and KRAS. The company has positioned its chemistry platform to address the dual challenges of kinase resistance and CNS metastases, and in June 2026 signed a partnership with GSK giving GSK ex-US rights to two of its kinase inhibitors in a deal structured to take advantage of a post-ASCO share-price dip.
Company Info
Sector:Biopharmaceutical / Oncology (Kinase Inhibitors)
Headquarters:Cambridge, Massachusetts, USA
Founded:2017
Website:nuvalent.com/
Upcoming Milestones & Key Dates
H2 2026
Business Development
GSK partnership close for ex-US rights to NVL-520 and NVL-655
Q4 2026
Clinical Trial
Updated ARROS-1 and ALKOVE-1 dose-expansion data
Clinical Development Pipeline
NVL-520 (zidesamtinib)
Target: Brain-penetrant, resistance-selective ROS1 inhibitorNVL-655 (neladalkib)
Target: Brain-penetrant, resistance-selective ALK inhibitorNVL-330
Target: Brain-penetrant, selective HER2 exon-20 / atypical mutant inhibitorRecent News
Jideytro (zidesamtinib) approved in the US for previously treated ROS1-positive non-small cell lung cancer
Jideytro (zidesamtinib) approved in the US for previously treated ROS1-positive non-small cell lung cancer.
Nuvalent shares surge 39% after UK's GSK agrees to buy the cancer drugmaker for $10.6 billion
Nuvalent shares surge 39% after UK's GSK agrees to buy the cancer drugmaker for $10.6 billion.
Leadership Team
James R. Porter
Co-Founder, Chief Executive Officer and Chief Scientific Officer
Dr. Henry Adewoye
Senior Vice President, Clinical Development
Careers & Job Openings