Business
Nuvalent Announces Key Program and Business Updates, Strengthening Foundation for Global Leadership in ROS1- and ALK-positive NSCLC
Nuvalent Announces Key Program and Business Updates, Strengthening Foundation for Global Leadership in ROS1- and ALK-positive NSCLC
About this update from Nuvalent, Inc.
[{"type":"text","content":"New Drug Application for neladalkib in TKI pre-treated advanced ALK-positive NSCLC accepted for filing with Priority Review by the FDA with PDUFA target action date of November 27, 2026Veteran biopharmaceutical executive, Georg Pirmin Meyer, M.D., joins as Chief International Officer to lead Nuvalent's global expansion strategyCAMBRIDGE, Mass., May 27, 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 announced the acceptance of its New Drug Application (NDA) for neladalkib for filing by the U.S. Food and Drug Administration (FDA). The FDA has granted the application Priority Review and assigned a Prescription Drug User Fee Act (PDUFA) target action date of November 27, 2026. The company further announced that Georg Pirmin Meyer, M.D., has joined the company as Chief International Officer.\n \n \n \n \n \n\"With today's announcement, New Drug Applications for both zidesamtinib and neladalkib in TKI pre-treated populations are now under review with the FDA, and TKI-naïve expansion strategies are underway,\" said James Porter, Ph.D., Chief Executive Officer of Nuvalent. \"Our U.S. commercial and medical affairs teams are in place and focused on establishing the strong foundational systems and infrastructure required to effectively deliver on multiple synergistic launches in biomarker-driven NSCLC.\"Dr. Porter continued, \"Nuvalent's commitment to patients is global, and we are thrilled to welcome Georg Pirmin as we develop an international strategy with the goal of delivering new medicines beyond the U.S. His proven track record of establishing global operations and strategic partnerships that maximize patient access will be instrumental in realizing the full potential for Patient Impact with our parallel-lead programs.\"\"Nuvalent presents a unique near-term opportunity to advance multiple potential best-in-class product candidates for patients with cancer, backed by robust clinical experience demonstrating clear global medical need and enthusiasm,\" said Dr. Meyer. \"I am excited to join at this pivotal moment and to partner with the team to realize our shared vision of global leadership in ROS1- and ALK-positive NSCLC.\"Neladalkib NDA Accepted for Filing with Priority Review The U.S...