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Nuvalent Announces OnTarget 2026 Operating Plan Progress and Outlines Key Anticipated 2026 Milestones
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 outlined key anticipated milestones towards its first potential U.S. commercial launch under its "OnTarget 2026" operating plan.
About this update from Nuvalent, Inc.
[{"type":"text","content":"FDA accepted NDA for zidesamtinib for the treatment of TKI pre-treated patients with advanced ROS1-positive NSCLC; PDUFA target action date of September 18, 2026","length":166,"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 indication expansion of zidesamtinib in TKI-naïve advanced ROS1-positive NSCLC population planned for the second half of 2026","length":150,"tagName":"p","attribs":{}},{"type":"text","content":"Well capitalized with operating runway anticipated into 2029","length":60,"tagName":"p","attribs":{}},{"type":"text","content":"Company to present at 44th Annual J.P. Morgan Healthcare Conference on Tuesday, January 13th at 9:00 a.m. PT","length":108,"tagName":"p","attribs":{}},{"type":"text","content":"CAMBRIDGE, Mass., Jan. 12, 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 highlighted pipeline progress and outlined key anticipated milestones towards its first potential U.S. commercial launch under its "OnTarget 2026" operating plan.","length":417,"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 part of this plan, Nuvalent anticipates the following 2026 milestones:","length":73,"tagName":"p"},{"type":"list","items":[{"val":[{"type":"text","content":"Commercial launch in the U.S. of zidesamtinib for the treatment of adult patients with locally advanced or met...