Business
Nuvalent Highlights Pipeline Progress and Reports Second Quarter 2023 Financial Results
Continued execution across pipeline with clinical trials ongoing for NVL-520 and NVL-655, and advancement of NVL-330 toward clinical development Preliminary
About this update from Nuvalent, Inc.
[{"type":"text","content":"Continued execution across pipeline with clinical trials ongoing for NVL-520 and NVL-655, and advancement of NVL-330 toward clinical development\nPreliminary dose-escalation data anticipated from ongoing ALKOVE-1 study of NVL-655 for patients with advanced ALK-positive NSCLC and other solid tumors at a medical meeting in the fourth quarter of 2023\n$431.2 million in cash, cash equivalents and marketable securities expected to support operating runway into the second half of 2025\nCAMBRIDGE, Mass., Aug. 10, 2023 /PRNewswire/ -- Nuvalent, Inc. (Nasdaq: NUVL), a clinical-stage biopharmaceutical company focused on creating precisely targeted therapies for clinically proven kinase targets in cancer, today highlighted pipeline progress and reported second quarter 2023 financial results.\n\n \n \n \n \n \n \n\n \n\"As we enter the second half of 2023, we are well positioned to continue advancing our pipeline of novel kinase inhibitors,\" said James Porter, Ph.D., Chief Executive Officer at Nuvalent. \"The focused efforts of our team in the first half of 2023 have laid the foundation for a number of meaningful development milestones, including the planned reporting of preliminary Phase 1 data at a medical meeting in the fourth quarter of the year from the dose-escalation portion of our ALKOVE-1 Phase 1/2 trial of NVL-655. Additionally, progress continues towards the selection of a recommended Phase 2 dose and transition to Phase 2 in our ARROS-1 Phase 1/2 trial of NVL-520, and the submission of a new IND application for NVL-330 for the treatment of patients with HER2 exon 20 insertion-positive cancers. I'm incredibly proud of what this team has accomplished to date and look forward to providing further updates later on this year.\"\nPipeline Highlights and Key Anticipated Milestones\nPreliminary Data from ALKOVE-1 Phase 1/2 Trial of NVL-655 Anticipated at a Medical Meeting in the Fourth Quarter of 2023: NVL-655 is a brain-penetrant 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 first-, second-, and third-generation ALK inhibitors. Our ALKOVE-1 clinical trial is a first-in-human Phase 1/2, multicenter, open-label, dose-escalation and expansion study evaluating NVL-655 as a...