Nuvalent, Inc. Class A (NUVL)

In June 2025, Nuvalent announced positive pivotal data from the ARROS-1 Phase 1/2 clinical trial for zidesamtinib, which demonstrated an ORR of 44% in 117 patients, with 78% durability at 12 months. In July 2025, following the positive ARROS-1 data, Nuvalent initiated a rolling NDA submission for zidesamtinib, targeting completion in the third quarter of 2025. In October 2025, Nuvalent presented preliminary data for Neladalkib in advanced ALK-positive solid tumors beyond NSCLC at ESMO 2025, showing encouraging preliminary activity. Also in October 2025, Deborah Ann Miller, Chief Legal Officer and Secretary, sold 12,376 shares of Nuvalent stock for a total of $1,134,384.16.

As a clinical-stage biopharmaceutical company without approved products, Nuvalent does not experience traditional demand seasonality. Its financial health is primarily supported by funding for research and development.

Nuvalent, Inc. is a clinical-stage biopharmaceutical company focused on developing precisely targeted therapies for cancer patients. The company is creating innovative small molecules to overcome resistance, minimize adverse events, and achieve more durable responses in patients with clinically proven kinase targets in cancer. Its pipeline includes Zidesamtinib (NVL-520), a ROS1-selective inhibitor; Neladalkib (NVL-655), a brain-penetrant ALK-selective inhibitor; and NVL-330, a brain-penetrant HER2-selective inhibitor.

Nuvalent, Inc. is headquartered in Cambridge, Massachusetts, United States. Its clinical trials, such as ARROS-1, ALKOVE-1, ALKAZAR, and HEROex-1, involve global enrollment, indicating a broader international reach for its research and development activities.

Nuvalent's brand reputation has been positively influenced by its advancements in clinical development and positive trial results. Key events include receiving U.S. FDA Breakthrough Therapy Designation for NVL-520 in February 2024, initiating the Phase 2 portion of the ALKOVE-1 clinical trial for NVL-655 in February 2024, presenting positive pivotal data from the ARROS-1 clinical trial for zidesamtinib in June and September 2025, initiating a rolling NDA submission for zidesamtinib in July 2025, and presenting new preclinical data for its HER2-selective inhibitor, NVL-330, and preliminary data for Neladalkib (NVL-655) in October 2025.

Nuvalent, Inc. stock is primarily held by institutional shareholders, who own approximately 99.70% of the company, and insiders, holding about 33.10%. Major institutional owners include Deerfield Management Company LP, Fmr LLC, Paradigm Biocapital Advisors LP, Vanguard Group Inc., and BlackRock, Inc. The largest individual shareholder is James E. Flynn, who owns 18.65 million shares, representing 25.86% of the company.