Nuvalent Highlights Recent Pipeline Progress, Reiterates Key Anticipated Milestones, and Reports First Quarter 2026 Financial Results

NDA submitted for neladalkib in TKI pre-treated advanced ALK-positive NSCLC NDA for zidesamtinib in TKI pre-treated advanced ROS1-positive NSCLC under FDA review with PDUFA target action date of September 18, 2026 Submission for potential label expansion of zidesamtinib in TKI-naïve advanced ROS1-positive NSCLC planned for the second half of 2026 Strengthened leadership team with key internal promotions CAMBRIDGE, Mass., May 7, 2026 /PRNewswire/ -- Nuvalent, Inc. (Nasdaq: NUVL), a clinical-stage biopharmaceutical company focused on creating precisely targeted therapies for clinically proven kinase targets in cancer, today outlined pipeline progress, reiterated key anticipated milestones, and reported first quarter 2026 financial results.