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Jun 9, 2026Multi-product oncology deal for assets that have validated targets and aim to address efficacy and/or tolerability limitations of existing therapies
GSK plc (LSE/NYSE: GSK) today announced that it has entered an agreement to acquire Nuvalent, Inc. (“Nuvalent”) (NASDAQ: NUVL) a Boston-based clinical-stage biopharmaceutical company focused...
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May 27, 2026New Drug Application for neladalkib in TKI pre-treated advanced ALK-positive NSCLC accepted for filing with Priority Review by the FDA with PDUFA target action date of November 27, 2026
New Drug Application for neladalkib in TKI pre-treated advanced ALK-positive NSCLC accepted for filing with Priority Review by the FDA with PDUFA target action date of November 27, 2026 Veteran...
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May 21, 2026Presentation of pivotal data for neladalkib in TKI pre-treated patients with advanced ALK-positive NSCLC from ALKOVE-1 trial
Presentation of pivotal data for neladalkib in TKI pre-treated patients with advanced ALK-positive NSCLC from ALKOVE-1 trial TKI pre-treated data from ALKOVE-1 trial of neladalkib support recent...
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May 7, 2026NDA submitted for neladalkib in TKI pre-treated advanced ALK-positive NSCLC
NDA submitted for neladalkib in TKI pre-treated advanced ALK-positive NSCLC NDA for zidesamtinib in TKI pre-treated advanced ROS1-positive NSCLC under FDA review with PDUFA target action date of...
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Apr 21, 2026Company to also present preliminary data for zidesamtinib in advanced ROS1-positive solid tumors outside of NSCLC from the global ARROS-1 trial
Company to also present preliminary data for zidesamtinib in advanced ROS1-positive solid tumors outside of NSCLC from the global ARROS-1 trial CAMBRIDGE, Mass., April 21, 2026 /PRNewswire/ --...
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Apr 17, 2026Zidesamtinib demonstrated meaningful clinical activity in subset of TKI pre-treated ROS1-positive NSCLC patients from ARROS-1 trial previously treated with repotrectinib or taletrectinib, including in those with CNS disease or ROS1 resistance mutations
Zidesamtinib demonstrated meaningful clinical activity in subset of TKI pre-treated ROS1-positive NSCLC patients from ARROS-1 trial previously treated with repotrectinib or taletrectinib,...
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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...
The information in Nuvalent’s press releases is accurate only as of the date of issuance. Nuvalent assumes no duty to update or revise the information contained in the press releases after their original release date.
