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Apr 7, 2026New Drug Application (NDA) based on data in TKI pre-treated patients from the global ALKOVE-1 Phase 1/2 clinical trial
New Drug Application (NDA) based on data in TKI pre-treated patients from the global ALKOVE-1 Phase 1/2 clinical trial CAMBRIDGE, Mass., April 7, 2026 /PRNewswire/ -- Nuvalent, Inc. (Nasdaq:...
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Mar 17, 2026
Nuvalent, Inc. (Nasdaq: NUVL), a clinical-stage biopharmaceutical company focused on creating precisely targeted therapies for clinically proven kinase targets in cancer, today announced the...
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Feb 26, 2026Commercial 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
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...
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Feb 5, 2026
Nuvalent, Inc. (Nasdaq: NUVL), a clinical-stage biopharmaceutical company focused on creating precisely targeted therapies for clinically proven kinase targets in cancer, today announced that...
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Jan 12, 2026FDA 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
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 NDA submission for neladalkib in...
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