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companiesCompany
Nuvalent
Designer of cleaner kinase inhibitors; zidesamtinib (ROS1) approved July 2026, neladalkib (ALK) next.
Overview
Nuvalent, based in Cambridge, Massachusetts, and listed as NUVL, designs kinase inhibitors that are cleaner than their predecessors; zidesamtinib, its ROS1 inhibitor, was approved in July 2026 as Jideytro, and neladalkib, its ALK inhibitor, is next. Neladalkib is being tested in the ALKOVE-1 trial and a HER2-selective programme follows. OnCo links it to non-small-cell lung cancer and to the zidesamtinib and neladalkib drug records. Whether selectivity translates into fewer side effects and longer control than existing ROS1 and ALK drugs in routine use is the open question. Zidesamtinib has its own page.
Headquarters
Cambridge, MA, US
Scorecard
All companies#250of 1244 companies, score 20
- approved products +6
- phase 3 +3
- targets +2
- modalities +2
- regions +1
- 24-month regulatory events +2
- registry trials +4
1 approved, 1 in phase 3, 0 earlier, 1 targets, 4 registry studies. Formula on the scorecards page.
Catalysts
What is due next- 18 September 2026confirmedFDA decision: zidesamtinib in TKI-pretreated ROS1-positive NSCLC
PDUFA target action date stated by Nuvalent when the FDA accepted the new drug application. Nuvalent's first potential approval. Source
Type
Biotech · NUVL
Stage
Public
Website
ApprovedSmall-molecule kinase inhibitor (ROS1)
Zidesamtinib · Jideytro
A ROS1 inhibitor approved in July 2026 that works after other ROS1 drugs fail and avoids their brain side effects.
Phase 3Small-molecule kinase inhibitor (ALK)
A fourth-generation ALK pill that works after lorlatinib and avoids the TRK-related brain side effects; under FDA priority review with a decision due 27 November 2026.
Similar pages
- TargetNVL
Shares A Study of Zidesamtinib (NVL-520) in Patients With Advanced NSCLC and Other Solid Tumors Harboring ROS1 Rearrangement (ARROS-1), Neladalkib (NVL-655) for TKI-naive Patients With Advanced ALK-Positive NSCLC.
- TrialNeoadjuvant WX-0593 in Resectable ALK-positive or ROS1-positive Non-small Cell Lung Cancer
Shares ROS1-positive non-small-cell lung cancer, ALK-positive non-small-cell lung cancer, Non-small-cell lung cancer.
- TrialA Study Evaluates the Safety and Efficacy of WX-0593 in ALK -Positive, or ROS1-positive Non-small Cell Lung Cancer
Shares ROS1-positive non-small-cell lung cancer, ALK-positive non-small-cell lung cancer, Non-small-cell lung cancer.
- TreatmentAlectinib
Shares Neladalkib (NVL-655) for TKI-naive Patients With Advanced ALK-Positive NSCLC, Neladalkib, ALK-positive non-small-cell lung cancer, Targeted therapy roadmap: imatinib → designed for resistance → the undruggable drivers fall.
- TrialBasket Study of Entrectinib (RXDX-101) for the Treatment of Patients With Solid Tumors Harboring NTRK 1/2/3 (Trk A/B/C), ROS1, or ALK Gene Rearrangeme
Shares ROS1-positive non-small-cell lung cancer, ALK-positive non-small-cell lung cancer, Non-small-cell lung cancer.
- TrialALINA
Shares ALK-positive non-small-cell lung cancer, Targeted therapy roadmap: imatinib → designed for resistance → the undruggable drivers fall, Non-small-cell lung cancer.
- PersonD. Ross Camidge
Shares ROS1-positive non-small-cell lung cancer, ALK-positive non-small-cell lung cancer, Non-small-cell lung cancer.
- IdeactDNA-guided dose holidays for lung cancer targeted therapy
Shares ALK-positive non-small-cell lung cancer, Targeted therapy roadmap: imatinib → designed for resistance → the undruggable drivers fall, Non-small-cell lung cancer.
cancers
fronts
drugs
Phase 3Small-molecule kinase inhibitor (ALK)
ApprovedSmall-molecule kinase inhibitor (ROS1)
Zidesamtinib · Jideytro