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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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