Business
Nuvalent Highlights Pipeline and Business Progress and Reports First Quarter 2022 Financial Results
Two clinical-stage programs ongoing for potential best-in-class ROS1 and ALK-selective inhibitors On-track for selection of two additional development
About this update from Nuvalent, Inc.
[{"type":"text","content":"Two clinical-stage programs ongoing for potential best-in-class ROS1 and ALK-selective inhibitors\nOn-track for selection of two additional development candidates in 2022 \nEnded the first quarter of 2022 with $272.7 million in cash, cash equivalents, and marketable securities to support planned operations into 2024\nCAMBRIDGE, Mass., May 12, 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 first quarter 2022 financial results.\n\n \n \n \n \n \n \n\n \n\"At Nuvalent, we're building a fully integrated biotech company with the goal to design, develop, and deliver a portfolio of best-in-class therapies for patients with cancer. We view 2022 as a critical year of execution and we have already made meaningful progress across our pipeline. Enrollment is progressing well in the ongoing Phase 1 portion of our ARROS-1 Phase 1/2 trial of NVL-520 for advanced ROS1-positive NSCLC and other solid tumors, and following the recently announced clearance of the IND for NVL-655, we are on track for planned initiation of our ALKOVE-1 Phase 1/2 study for advanced ALK-positive NSCLC and other solid tumors in the second quarter of 2022,\" said James Porter, Ph.D., Chief Executive Officer at Nuvalent. \"By year-end, our team has the potential to have delivered four novel development candidates since company formation, with two clinical trials underway. With an exceptional team and strong foundation in place, I am confident in our ability to bring precisely targeted therapies that can enable deeper and more durable responses to patients with cancer.\"\nUpcoming Pipeline MilestonesALKOVE-1 Trial of NVL-655 for Patients with ALK-positive Non-Small Cell Lung Cancer (NSCLC) Expected to Begin in Second Quarter of 2022: Nuvalent has received confirmation from the U.S. Food and Drug Administration (FDA) that its Investigational New Drug (IND) application for NVL-655 has been cleared. The company is on track to initiate the ALKOVE-1 Phase 1/2 study of NVL-655 for patients with advanced ALK-positive NSCLC and other solid tumors, anticipated in the second quarter of 2022. NVL-655 is a novel ALK-selective inhibitor designed to address the clinical challenges of emergent tr...