Business
Nuvalent Outlines Recent Pipeline Progress, Reiterates Key Anticipated Milestones, and Reports Fourth Quarter and Full Year 2025 Financial Results
Nuvalent, Inc. (Nasdaq: NUVL), a clinical-stage biopharmaceutical company focused on creating precisely targeted therapies for clinically proven kinase targets in cancer, today outlined pipeline progress, reiterated key anticipated milestones, and reported fourth quarter and full year 2025 financial results.
About this update from Nuvalent, Inc.
[{"type":"text","content":"Commercial preparations well underway to support potential U.S. launch of zidesamtinib in TKI pre-treated advanced ROS1-positive NSCLC population, pending FDA review; PDUFA target action date of September 18, 2026","length":213,"tagName":"p","attribs":{}},{"type":"text","content":"NDA submission for neladalkib in TKI pre-treated advanced ALK-positive NSCLC population planned for the first half of 2026","length":122,"tagName":"p","attribs":{}},{"type":"text","content":"Submission for potential label expansion of zidesamtinib in TKI-naïve advanced ROS1-positive NSCLC population planned for the second half of 2026","length":145,"tagName":"p","attribs":{}},{"type":"text","content":"Strong financial position with operating runway anticipated into 2029","length":69,"tagName":"p","attribs":{}},{"type":"text","content":"CAMBRIDGE, Mass., Feb. 26, 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 outlined pipeline progress, reiterated key anticipated milestones, and reported fourth quarter and full year 2025 financial results.","length":357,"tagName":"p"},{"type":"image","alt":"Nuvalent, Inc. (PRNewsfoto/Nuvalent, Inc.)","displaySize":"","headline":null,"caption":"Nuvalent, Inc. (PRNewsfoto/Nuvalent, Inc.)","className":"","disableSlideshowImg":false,"size":{"original":{"width":400,"height":119,"url":"https://media.zenfs.com/en/prnewswire.com/006d4b5652d5dd7204d997761f53cb52"},"resized":{"url":"https://s.yimg.com/ny/api/res/1.2/nyXXCgJnZ0hzAj35VSao2Q--/YXBwaWQ9aGlnaGxhbmRlcjt3PTcwNTtoPTIxMDtjZj13ZWJw/https://media.zenfs.com/en/prnewswire.com/006d4b5652d5dd7204d997761f53cb52","width":400,"height":119}},"href":"https://mma.prnewswire.com/media/1583941/Nuvalent_Inc_Logo_2024.html","hrefExternal":true,"rel":"nofollow"},{"type":"text","content":""As we advance toward the culmination of our OnTarget 2026 operating plan with a first potential FDA approval targeted for later this year, our focus remains on applying the disciplined, patient-centric approach that has enabled rapid progress in discovery and development across our pipeline towards building the capabilities needed to effectively deliver new medicines to patients," said James Porter, Ph.D., Chief Executive Officer at Nuvalent. &qu...