Nuvalent, Inc. Class A (NUVL)

Nuvalent's stock has been influenced by several events. In January 2026, the FDA accepted the NDA for zidesamtinib, leading to positive market sentiment, though there was also downward pressure. In December 2025, insider share sales were disclosed, and the company announced its participation in the J.P. Morgan Healthcare Conference and appointed a new board member. In November 2025, positive data from the ALKOVE-1 trial led to a public offering and a royalty deal, with Truist Securities initiating coverage with a Buy rating. In Q3 2025, Nuvalent completed the NDA submission for zidesamtinib. In May 2024, the FDA granted Breakthrough Therapy Designation to neladalkib.

As a clinical-stage biopharmaceutical company, Nuvalent, Inc. currently generates no revenue from product sales and has no discernible demand seasonality. Demand seasonality would typically become a factor once the company has approved products on the market generating commercial revenue.

Nuvalent, Inc. is a clinical-stage biopharmaceutical company in Cambridge, Massachusetts, focused on developing targeted small-molecule therapies for cancer, particularly kinase-driven tumors. The company operates within the Biotechnology and Medical - Biomedical and Genetics industries, with revenue expected from product sales after regulatory approval, likely in 2026 or later. Key products include Zidesamtinib (NVL-520), a ROS1-selective inhibitor with a completed NDA submission and FDA acceptance, Neladalkib (NVL-655), an ALK-selective inhibitor with positive topline data and Breakthrough Therapy Designation, and NVL-330, a HER2-selective inhibitor in Phase 1a/1b clinical trial.

Nuvalent, Inc. is headquartered in Cambridge, Massachusetts, United States. While the company is involved in global clinical trials, specific international offices or major market presences beyond its U.S. headquarters are not detailed.

Nuvalent's brand reputation has been largely positive due to developments in its cancer therapies and analyst support. The FDA's acceptance of the NDA for zidesamtinib, Breakthrough Therapy Designation for neladalkib, and positive clinical trial data from the ALKOVE-1 trial have bolstered its reputation. The company consistently receives positive ratings from analysts. However, insider selling of shares has stirred some debate.

Nuvalent, Inc. is predominantly owned by institutional shareholders, accounting for 99.60% of the company, with 31.94% held by Nuvalent insiders and 0.00% by retail investors. Major institutional owners include Deerfield Management Company LP, Fmr LLC, Paradigm Biocapital Advisors Lp, Vanguard Group Inc, BlackRock, Inc., Wellington Management Group Llp, Janus Henderson Group Plc, Price T Rowe Associates Inc /md/, and Jpmorgan Chase & Co. The largest individual shareholder is James E. Flynn, owning 17.90 million shares, representing 24.62% of the company.