Business
Nuvalent Announces Business and Program Highlights and Reports Second Quarter 2021 Financial Results
IND Application for NVL-520 Cleared by US FDA; Company Expects to Initiate Phase 1/2 Clinical Trial in Second Half of 2021 $190.6 Million Upsized IPO
About this update from Nuvalent, Inc.
[{"type":"text","content":"IND Application for NVL-520 Cleared by US FDA; Company Expects to Initiate Phase 1/2 Clinical Trial in Second Half of 2021\n $190.6 Million Upsized IPO Completed to Fund Continued Advancement of Novel Portfolio of Precisely Targeted Kinase Inhibitors\n Leadership Team Further Strengthened with Appointments of Deborah Miller, Ph.D., J.D., as Chief Legal Officer and Sapna Srivastava, Ph.D., to the Board of Directors\n\n\nCAMBRIDGE, Mass., Sept. 8, 2021 /PRNewswire/ -- Nuvalent, Inc., (Nasdaq: NUVL), a biopharmaceutical company focused on creating precisely targeted therapies for clinically proven kinase targets in cancer, today reported recent pipeline and business highlights and second quarter 2021 financial results.\n\n \n \n \n \n \n \n\n \n\"At Nuvalent, we are leveraging our team's deep expertise in chemistry and structure-based drug design to advance a novel pipeline of product candidates for patients with cancer. Our therapies are specifically designed to solve for challenges limiting the activity and durability of currently available therapies, such as kinase resistance, adverse events due to off-target activity, and metastases to the brain,\" said James Porter, Ph.D., Chief Executive Officer at Nuvalent. \"In the first half of 2021, our team has made meaningful progress to deliver on our clear vision for advancing the field of precision oncology. We have received clearance from the FDA to proceed with the Phase 1/2 study for our ROS1-selective inhibitor NVL-520, advanced our parallel lead product candidate, the ALK-selective inhibitor NVL-655, into IND-enabling studies, and progressed multiple additional discovery-stage research programs. With the recent talented additions to our team and capital raised in our upsized IPO, we stand well positioned to fuel our upcoming transition to a clinical organization and efforts to renew hope for patients in need.\"\nSecond Quarter Highlights\nIND Application for NVL-520 Cleared by FDA, Enabling Clinical Trial Initiation: The U.S. Food and Drug Administration (FDA) has cleared the company's Investigational New Drug (IND) application for NVL-520, its brain-penetrant ROS1-selective inhibitor. The company is preparing to initiate the Phase 1 portion of a global, Phase 1/2 clinical trial for NVL-520 in patients with ROS1-positive NSCLC and other advanced solid tumors in the second half o...