Nuvalent
Biopharmaceutical company focused on structure-based medicinal chemistry to develop selective, brain-penetrant small-molecule kinase inhibitors for oncology. Operates discovery through clinical development (IND-enabling through Phase 3) with capabilities in translational science, clinical operations, regulatory strategy, pharmacovigilance, biostatistics/data management, medical affairs, market access, and commercial readiness.
Industries
Nr. of Employees
medium (51-250)
Nuvalent
Patents
Solid forms, pharmaceutical compositions and preparation of heteroaromatic macrocyclic ether compounds
US-12630560-B2
View DetailsSolid forms, pharmaceutical compositions and preparation of heteroaromatic macrocyclic ether compounds
US-12043626-B2
View Details
Solid forms, pharmaceutical compositions and preparation of heteroaromatic macrocyclic ether compounds
US-12630560-B2
View DetailsSolid forms, pharmaceutical compositions and preparation of heteroaromatic macrocyclic ether compounds
US-12043626-B2
View DetailsProducts
Clinical development program: ROS1-selective, brain-penetrant kinase inhibitor
Development program for a ROS1-selective small-molecule inhibitor optimized for activity against resistance mutations and for CNS penetration; clinical studies include global Phase 1/2 and Phase 2 programs in ROS1-positive NSCLC and other ROS1-driven solid tumors.
Clinical development program: ALK-selective kinase inhibitor
Clinical development program for ALK-selective small-molecule inhibitors, including studies in tyrosine kinase inhibitor (TKI)-pretreated and TKI-naïve ALK-positive NSCLC populations.
Clinical development program: HER2-altered NSCLC small-molecule program
Early clinical development program targeting HER2-altered non-small cell lung cancer.
Early discovery programs for additional kinase targets
Platform discovery activities to identify and optimize small-molecule kinase inhibitors for oncology indications beyond the current clinical programs.
Clinical development program: ROS1-selective, brain-penetrant kinase inhibitor
Development program for a ROS1-selective small-molecule inhibitor optimized for activity against resistance mutations and for CNS penetration; clinical studies include global Phase 1/2 and Phase 2 programs in ROS1-positive NSCLC and other ROS1-driven solid tumors.
Clinical development program: ALK-selective kinase inhibitor
Clinical development program for ALK-selective small-molecule inhibitors, including studies in tyrosine kinase inhibitor (TKI)-pretreated and TKI-naïve ALK-positive NSCLC populations.
Clinical development program: HER2-altered NSCLC small-molecule program
Early clinical development program targeting HER2-altered non-small cell lung cancer.
Early discovery programs for additional kinase targets
Platform discovery activities to identify and optimize small-molecule kinase inhibitors for oncology indications beyond the current clinical programs.
Services
End-to-end clinical development services from IND-enabling through Phase 3 for selective small-molecule kinase inhibitor programs in oncology.
Operational framework to evaluate and provide potential access to investigational therapies for individual patients under applicable regulations.
Provision of medical information, a patient support program to assist access and reimbursement navigation, and established channels for adverse event and product complaint reporting.
Execution support for advisory boards, investigator-sponsored research coordination, thought-leader engagement, promotional and medical material review.
End-to-end clinical development services from IND-enabling through Phase 3 for selective small-molecule kinase inhibitor programs in oncology.
Operational framework to evaluate and provide potential access to investigational therapies for individual patients under applicable regulations.
Provision of medical information, a patient support program to assist access and reimbursement navigation, and established channels for adverse event and product complaint reporting.
Execution support for advisory boards, investigator-sponsored research coordination, thought-leader engagement, promotional and medical material review.
Expertise Areas
- Structure-based drug discovery
- Selective kinase inhibitor development and resistance mitigation
- CNS/brain-penetrant small-molecule optimization
- Translational pharmacology and in vivo efficacy modeling
Key Technologies
- Structure-based medicinal chemistry
- Kinase inhibitor design and resistance-focused optimization
- CNS penetration and brain exposure optimization
- Translational pharmacology and intracranial efficacy models
News & Updates
Company acquisition by GSK completed as of July 15, 2026 (announcement and related press releases linked on company site).
Announcement referenced on company site regarding approval of a ROS1-targeted therapy for previously treated ROS1-positive NSCLC.
Presentation of efficacy and safety data for a ROS1 program in TKI-naïve advanced/metastatic ROS1+ NSCLC (ARROS-1).
Presentation summarizing efficacy and safety findings for a ROS1-targeted program in advanced ROS1-positive solid tumors.
Preclinical data comparing brain penetration and intracranial activity of the ROS1-targeted candidate relative to other inhibitors.
Pivotal efficacy and safety data from the Phase 1/2 ARROS-1 trial in previously treated ROS1-positive NSCLC.
Company acquisition by GSK completed as of July 15, 2026 (announcement and related press releases linked on company site).
Announcement referenced on company site regarding approval of a ROS1-targeted therapy for previously treated ROS1-positive NSCLC.
Presentation of efficacy and safety data for a ROS1 program in TKI-naïve advanced/metastatic ROS1+ NSCLC (ARROS-1).
Presentation summarizing efficacy and safety findings for a ROS1-targeted program in advanced ROS1-positive solid tumors.
Preclinical data comparing brain penetration and intracranial activity of the ROS1-targeted candidate relative to other inhibitors.
Pivotal efficacy and safety data from the Phase 1/2 ARROS-1 trial in previously treated ROS1-positive NSCLC.