Nuvalent is a clinical-stage biopharmaceutical company developing precision small molecule kinase inhibitors for non-small cell lung cancer (NSCLC). Nuvalent's core thesis is that existing kinase inhibitors are limited by drug resistance as tumors mutate, off-target toxicity, and poor CNS penetration — and that more selective inhibitors can overcome these limitations. Nuvalent has two lead programs, both oral monotherapies targeting oncogenic driver mutations in NSCLC. Zidesamtinib targets ROS1-positive NSCLC, with an NDA accepted by the FDA and a PDUFA date of September 18, 2026, initially for patients who received at least one prior ROS1 TKI. Neladalkib targets ALK-positive NSCLC, with an NDA submission planned for the first half of 2026 for TKI pre-treated patients and a Phase 3 trial (ALKAZAR) underway against alectinib in TKI-naïve patients. A third program, NVL-330, is a HER2-selective inhibitor in Phase 1. Nuvalent's commercial strategy follows a standard oncology playbook: enter later lines of therapy first where unmet need is clearest, then expand into earlier lines with larger patient populations. Nuvalent retains worldwide rights to all programs, plans to commercialize in the U.S. through its own specialty sales force, and owes low single-digit royalties on net sales to Deerfield and Royalty Pharma. Nuvalent has no revenue and funds operations entirely from capital markets.