Business
Nuvalent Reports Pipeline and Business Progress and Fourth Quarter and Full Year 2021 Financial Results
NVL-655 IND cleared by FDA, supporting planned initiation of ALKOVE-1 Phase 1/2 clinical trial in patients with ALK-positive NSCLC and other solid tumors in
About this update from Nuvalent, Inc.
[{"type":"text","content":"NVL-655 IND cleared by FDA, supporting planned initiation of ALKOVE-1 Phase 1/2 clinical trial in patients with ALK-positive NSCLC and other solid tumors in second quarter of 2022\nEnrollment ongoing in ARROS-1 trial of NVL-520 for advanced ROS1-positive NSCLC and other solid tumors\nDiscovery pipeline continues to advance toward two development candidate nominations in 2022\nCAMBRIDGE, Mass., March 29, 2022 /PRNewswire/ -- Nuvalent, Inc. (Nasdaq: NUVL), a clinical-stage biopharmaceutical company focused on creating precisely targeted therapies for clinically proven kinase targets in cancer, today reported pipeline and business progress and fourth quarter and full year 2021 financial results.\n\n \n \n \n \n \n \n\n \nAs part of today's update, Nuvalent is announcing that its Investigational New Drug (IND) application for NVL-655 for the treatment of ALK-positive NSCLC and other solid tumors was cleared by the U.S. Food and Drug Administration (FDA). NVL-655 is a novel ALK-selective inhibitor designed with the aim to address the clinical challenges of emergent treatment resistance, central nervous system (CNS)-related adverse events, and brain metastases that may limit the use of currently available ALK inhibitors. Nuvalent plans to initiate the ALKOVE-1 Phase 1/2 study of NVL-655 for patients with advanced ALK-positive non-small cell lung cancer (NSCLC) and other solid tumors in the second quarter of 2022.\n\"The Nuvalent team has continued to demonstrate the ability to discover novel molecules with preclinical profiles suggesting best-in-class potential and to progress them efficiently into clinical development. With the clearance of our IND for NVL-655, Nuvalent is on track to have two parallel lead compounds in clinical trials by mid-year,\" said James Porter, Ph.D., Chief Executive Officer at Nuvalent. \"We believe we are well positioned with two clinical-stage, novel product candidates in areas of significant medical need, and sustainable internal discovery efforts with the goal of delivering multiple additional product candidates. I am incredibly proud of all that this team has accomplished and their continued dedication to advancing new potential therapeutic options for patients in need.\"\nRecent Pipeline Highlights\nEnrollment Ongoing in ARROS-1 Trial of NVL-520 for Patients with Advanced ROS1-positive NSCLC: Nuvalent ...