Nuvalent, Inc.
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- Nuvalent, Inc. (Nasdaq: NUVL) is a clinical-stage biopharmaceutical company focused on creating precisely targeted therapies for clinically proven kinase targets in patients with cancer. Founded in 2017 and headquartered in Cambridge, Massachusetts, the company leverages expertise in chemistry and structure-based drug design to develop small-molecule inhibitors that overcome resistance, minimize adverse events, address brain metastases, and drive durable responses; its operations are primarily conducted in the United States, targeting oncology patients with non-small cell lung cancer (NSCLC) and other solid tumors. Nuvalent advances a robust pipeline featuring lead candidates zidesamtinib (NVL-520), a novel brain-penetrant ROS1-selective inhibitor in Phase 2 of the ARROS-1 trial for TKI-pretreated and naive advanced ROS1-positive NSCLC and other solid tumors; neladalkib (NVL-655), a brain-penetrant ALK-selective inhibitor in Phase 2 of the ALKOVE-1 trial for advanced ALK-positive NSCLC and other solid tumors, with the ALKAZAR Phase 3 trial initiated in July 2025 for TKI-naive ALK-positive NSCLC; and NVL-330, a brain-penetrant HER2-selective inhibitor in Phase 1 of the HEROEX-1 trial for HER2-altered NSCLC, alongside multiple discovery-stage programs. Recent milestones include the completion of a rolling New Drug Application (NDA) submission for zidesamtinib in TKI-pretreated advanced ROS1-positive NSCLC patients in Q3 2025, with FDA acceptance under the Real-Time Oncology Review pilot program and presentation of supporting pivotal data from the ARROS-1 trial at the IASLC 2025 World Conference on Lung Cancer; positive pivotal data readout for zidesamtinib in June 2025 aligning with FDA on NDA strategy; initiation of the ALKAZAR Phase 3 trial for neladalkib in July 2025; FDA Breakthrough Therapy Designation for neladalkib received earlier in 2025; appointment of Christy Oliger to the board in June 2025; and publication in Molecular Cancer Therapeutics reinforcing zidesamtinib's design rationale in April 2025, alongside ongoing enrollment and preclinical data presentations at major conferences including AACR and ASCO.
Nuvalent Announces Key Program and Business Updates, Strengthening Foundation for Global Leadership in ROS1- and ALK-positive NSCLC
Nuvalent Highlights Upcoming Data Presentations for Neladalkib and Zidesamtinib at the 2026 American Society of Clinical Oncology Annual Meeting
Nuvalent Highlights Recent Pipeline Progress, Reiterates Key Anticipated Milestones, and Reports First Quarter 2026 Financial Results
Nuvalent: A Precision Oncology Platform With Two Near-Term Shots On Goal
Guardant Health Announces Multi-Year Strategic Collaboration with Nuvalent to Develop Companion Diagnostics and Support Potential Commercialization of Targeted Cancer Therapies Using the Guardant Infinity™ Platform
Evergreen Capital Management LLC Purchases New Position in Nuvalent, Inc. $NUVL
Nuvalent to Present Pivotal Data from ALKOVE-1 Trial of Neladalkib in TKI Pre-treated Advanced ALK-positive NSCLC at the 2026 American Society of Clinical Oncology Annual Meeting
New Clinical and Preclinical Data for Investigational Candidate Zidesamtinib Presented at AACR Annual Meeting 2026
Nuvalent Announces Submission of New Drug Application to FDA for Neladalkib in TKI Pre-treated Advanced ALK-positive NSCLC
Alexandra Balcom Sells 11,430 Shares of Nuvalent (NASDAQ:NUVL) Stock
Nuvalent to Present New Preclinical and Clinical Data for Zidesamtinib, an Investigational ROS1-Selective Inhibitor, at AACR Annual Meeting 2026
Nuvalent, Inc. (NASDAQ:NUVL) Given Average Rating of “Moderate Buy” by Analysts
This Investor Sold $104 Million of Nuvalent Stock Amid Cancer Drug Developer's Nearly 30% Rally
Nuvalent, Inc. $NUVL Shares Sold by ArrowMark Colorado Holdings LLC
Does Nuvalent (NUVL) Have the Potential to Rally 37.26% as Wall Street Analysts Expect?
Nuvalent Outlines Recent Pipeline Progress, Reiterates Key Anticipated Milestones, and Reports Fourth Quarter and Full Year 2025 Financial Results
Biotech Fund Dumps $84 Million of Nuvalent With Stock Up 29%
Nuvalent Details FDA Timelines for ROS1, ALK Drugs as $1.4B Cash Fuels Global Launch Plans
Nuvalent to Participate in the Guggenheim Emerging Outlook: Biotech Summit 2026
Nuvalent, Inc. (NASDAQ:NUVL) Given Consensus Recommendation of “Moderate Buy” by Brokerages