Nuvalent Outlines Recent Pipeline Progress, Reiterates Key Anticipated Milestones, and Reports Fourth Quarter and Full Year 2025 Financial Results

Group 1 - The company is preparing for the potential U.S. launch of zidesamtinib in TKI pre-treated advanced ROS1-positive NSCLC population, pending FDA review with a PDUFA target action date of September 18, 2026 [1] - The company plans to submit a New Drug Application (NDA) for neladalkib in TKI pre-treated advanced ALK-positive NSCLC population in the first half of 2026 [1] - There is a planned submission for potential label expansion of zidesamtinib in TKI-naïve advanced ROS1-positive NSCLC population in the second half of 2026 [1] Group 2 - The company reported a strong financial position with an operating runway anticipated into 2029 [1] - The company outlined pipeline progress and reiterated key anticipated milestones during the fourth quarter and full year 2025 financial results [1]