Business
Nuvalent Outlines Recent Pipeline and Business Progress, Reiterates Key Anticipated Milestones, and Reports First Quarter 2025 Financial Results
Topline pivotal data expected for zidesamtinib in TKI pre-treated ROS1-positive NSCLC population in the first half of 2025 in support of anticipated first NDA
About this update from Nuvalent, Inc.
[{"type":"text","content":"Topline pivotal data expected for zidesamtinib in TKI pre-treated ROS1-positive NSCLC population in the first half of 2025 in support of anticipated first NDA submission by mid-year 2025 \nInitiation of ALKAZAR Phase 3 randomized, controlled trial of neladalkib for front-line ALK-positive NSCLC planned for first half of 2025\nPivotal data for neladalkib in TKI pre-treated ALK-positive NSCLC population anticipated by year-end 2025\nStrengthened leadership team with key internal promotions\nCAMBRIDGE, Mass., May 8, 2025 /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 and business progress, reiterated key anticipated milestones, and reported first quarter 2025 financial results.\n\n \n \n \n \n \n \n\n \n\"2025 is a critical year of execution for Nuvalent as we continue to transition toward becoming a fully integrated commercial-stage biopharmaceutical company,\" said James Porter, Ph.D., Chief Executive Officer at Nuvalent. \"We expect multiple meaningful milestones this year, including pivotal data for TKI pre-treated patients from both of our parallel lead programs, and our first potential NDA submission for zidesamtinib for TKI pre-treated patients with ROS1-positive NSCLC.\"\nDr. Porter continued, \"The continued progress across our portfolio is a direct reflection of the strength and dedication of our team—it is their deep expertise, operational excellence, and commitment to patients that drive our ability to execute. In recognition of their significant contributions, we're pleased to announce the leadership promotions of Ruth Adams to Senior Vice President, Clinical Operations; Dr. Joshua Horan to Senior Vice President, Chemistry; and Jessie Lin to Senior Vice President, Corporate Strategy and Portfolio Management. With strong product candidates, a solid financial position, and an experienced team unified by an unwavering commitment to patient impact, we believe we are well-positioned to achieve our goals.\"\nRecent Pipeline and Business Highlights \nROS1 Program \nEvaluation of zidesamtinib, the company's novel ROS1-selective inhibitor, is ongoing in the ARROS-1 Phase 1/2 trial for patients with advanced TKI-naïve and TKI pre-treated ROS1-positive non-small cell l...