CAMBRIDGE, Mass. , Aug. 13, 2025 /PRNewswire/ -- 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 pivotal data for zidesamtinib, a novel ROS1-selective inhibitor, in TKI (tyrosine kinase inhibitor) pre-treated patients with advanced ROS1-positive non-small cell lung cancer (NSCLC) from the global ARROS-1 Phase 1/2 clinical trial, in addition to preliminary data for TKI-naïve patients, will be presented as part of the Presidential Symposium at the IASLC 2025 World Conference on Lung Cancer (WCLC 2025).
Initiated rolling NDA submission for zidesamtinib for TKI pre-treated patients with advanced ROS1-positive NSCLC, with target completion in the third quarter of 2025 Initiated ALKAZAR Phase 3 randomized, controlled trial of neladalkib for front-line ALK-positive NSCLC Topline pivotal data for neladalkib for TKI pre-treated patients with advanced ALK-positive NSCLC expected by year-end 2025 Preliminary data for neladalkib in patients with ALK-positive solid tumors beyond NSCLC to be presented at the ESMO Congress 2025 Jason Waters, MBA, promoted to Senior Vice President, Commercial CAMBRIDGE, Mass. , Aug. 7, 2025 /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 and business achievements, reiterated key anticipated milestones, and reported second quarter 2025 financial results.
CAMBRIDGE, Mass. , July 21, 2025 /PRNewswire/ -- 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 first patient has been dosed in ALKAZAR, the company's global Phase 3 randomized, controlled trial evaluating neladalkib for TKI-naïve patients with advanced ALK-positive non-small cell lung cancer (NSCLC), versus ALECENSA® (alectinib), a front-line standard of care.
Aligned with FDA on NDA submission strategy for TKI pre-treated patients with advanced ROS1-positive NSCLC and participation in Real-Time Oncology Review; the company plans to initiate a rolling NDA submission in July 2025 with target completion in the third quarter of 2025 In 117 ROS1 TKI pre-treated patients, including 50% who had received ≥ 2 prior ROS1 TKIs ± chemotherapy, ORR by BICR was 44% (95% CI: 34, 53) with initial estimated durability of response of 78% at the 12-month landmark and 62% at the 18-month landmark In the subset of 55 patients treated with 1 prior ROS1 TKI (crizotinib or entrectinib) ± chemotherapy, ORR was 51% (95% CI: 37, 65) with initial estimated durability of response of 93% at the 12- and 18-month landmarks Zidesamtinib demonstrated intracranial responses, activity against tumors with a ROS1 G2032R resistance mutation, and a generally well-tolerated safety profile, including low rates of dose reduction (10%) and discontinuation (2%), consistent with its ROS1-selective, TRK-sparing design Company announces progress in the front-line development strategies for its parallel lead programs in ROS1-positive and ALK-positive NSCLC Company to host a conference call today, June 24th at 8:00am ET CAMBRIDGE, Mass. , June 24, 2025 /PRNewswire/ -- Nuvalent, Inc. (Nasdaq: NUVL), a clinical-stage biopharmaceutical company focused on creating precisely targeted therapies for clinically proven kinase targets in cancer, today announced positive pivotal data for zidesamtinib, a novel ROS1-selective inhibitor, in TKI (tyrosine kinase inhibitor) pre-treated patients with advanced ROS1-positive non-small cell lung cancer (NSCLC) from the global ARROS-1 Phase 1/2 clinical trial.
Company to host webcast and conference call on June 24, 2025 at 8:00am ET CAMBRIDGE, Mass. , June 23, 2025 /PRNewswire/ -- 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 company will host a webcast and conference call on Tuesday, June 24, 2025 at 8:00 a.m.
CAMBRIDGE, Mass. , June 18, 2025 /PRNewswire/ -- 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 appointment of Christy Oliger to its Board of Directors.
Topline pivotal data expected for zidesamtinib in TKI pre-treated ROS1-positive NSCLC population in the first half of 2025 in support of anticipated first NDA submission by mid-year 2025 Initiation of ALKAZAR Phase 3 randomized, controlled trial of neladalkib for front-line ALK-positive NSCLC planned for first half of 2025 Pivotal data for neladalkib in TKI pre-treated ALK-positive NSCLC population anticipated by year-end 2025 Strengthened leadership team with key internal promotions CAMBRIDGE, Mass. , May 8, 2025 /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 and business progress, reiterated key anticipated milestones, and reported first quarter 2025 financial results.
CAMBRIDGE, Mass. , April 29, 2025 /PRNewswire/ -- 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 publication of a manuscript in Molecular Cancer Therapeutics, a journal of the American Association for Cancer Research, which supports the rational molecular design of zidesamtinib, its novel and selective ROS1 inhibitor.
CAMBRIDGE, Mass. , April 23, 2025 /PRNewswire/ -- Nuvalent, Inc. (Nasdaq: NUVL), a clinical-stage biopharmaceutical company focused on creating precisely targeted therapies for clinically proven kinase targets in cancer, today announced two "Trial in Progress" poster presentations for its novel ALK-selective inhibitor, neladalkib, and novel HER2-selective inhibitor, NVL-330, at the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting from May 30 – June 5, 2025, in Chicago.
CAMBRIDGE, Mass. , April 1, 2025 /PRNewswire/ -- 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 James Porter, Ph.D.
