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26.11.2025
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Nuvalent to Participate in the Piper Sandler 37th Annual Healthcare Conference
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CAMBRIDGE, Mass., Nov. 26, 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., Chief Executive Officer, and Alexandra Balcom, Chief Financial Officer, will participate...
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24.11.2025
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Nuvalent Announces Closing of Public Offering of Common Stock and Full Exercise by Underwriters of Option to Purchase Additional Shares from Selling Stockholders
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CAMBRIDGE, Mass., Nov. 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 the closing of its previously announced underwritten public offering of 4,950,496 shares of Class A common stock a...
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19.11.2025
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Nuvalent Announces FDA Acceptance of New Drug Application for Zidesamtinib for the Treatment of TKI Pre-treated Patients with Advanced ROS1-positive NSCLC
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NDA based on data from global
ARROS-1 Phase 1/2 clinical trial
FDA assigns PDUFA target action date of September 18, 2026
CAMBRIDGE, Mass., Nov. 19, 2025 /PRNewswire/ -- Nuvalent, Inc. (Nasda...
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19.11.2025
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Nuvalent Announces Pricing of Public Offering of Common Stock
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CAMBRIDGE, Mass., Nov. 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 pricing of an underwritten public offering of shares of Class A common stoc...
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20.10.2025
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17.11.2025
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Nuvalent Announces Public Offering of Common Stock
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CAMBRIDGE, Mass., Nov. 17, 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 it has commenced an underwritten public offering of shares of Class A comm...
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17.11.2025
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Nuvalent Announces Positive Topline Pivotal Data from ALKOVE-1 Clinical Trial of Neladalkib for TKI Pre-treated Patients with Advanced ALK-positive NSCLC
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In 253 ALK TKI pre-treated patients, ORR by BICR was 31% (95% CI: 26, 37), with initial estimated durability of response of 64% and 53% at the 12-month and 18-month landmarks, respectively
In the subset of 63 TKI pre-treated patients w...
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14.11.2025
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Nuvalent Announces Timing of Topline Pivotal Data for TKI Pre-treated Patients with Advanced ALK-positive NSCLC from ALKOVE-1 Clinical Trial of Neladalkib
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Company to host webcast and conference call on November 17, 2025 at 8:00am ET
CAMBRIDGE, Mass., Nov. 14, 2025 /PRNewswire/ -- Nuvalent, Inc. (Nasdaq: NUVL), a clinical-stage biopharmaceutical company focused on creating precisely targeted therapies for clinicall...
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04.11.2025
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Nuvalent to Present Patient-Reported Outcomes Data from ARROS-1 Trial of ROS1-Selective Inhibitor, Zidesamtinib, at 2025 IASLC ASCO North America Conference on Lung Cancer
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Encore pivotal efficacy and safety data from the ARROS-1 trial also to be presented during poster session
CAMBRIDGE, Mass., Nov. 4, 2025 /PRNewswire/ -- Nuvalent, Inc. (Nasdaq: NUVL), a clinical-stage biopharmaceutical company focused on creating precisely targe...
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18.10.2025
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Nuvalent Presents Preliminary Data for Neladalkib in Advanced ALK-positive Solid Tumors Beyond NSCLC at ESMO 2025
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Encouraging preliminary activity observed across diverse set of advanced ALK-positive solid tumors
Global enrollment ongoing for adult and adolescent patients with advanced ALK-positive solid tumors beyond NSCLC in a Phase 2 cohort of the ALKOVE-1 trial...
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13.10.2025
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Nuvalent to Present New Preclinical Data for HER2-Selective Inhibitor, NVL-330, at AACR-NCI-EORTC International Conference on Molecular Targets and Cancer Therapeutics
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CAMBRIDGE, Mass., Oct. 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 an upcoming poster presentation further characterizing the preclinical intracra...
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24.09.2025
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Nuvalent to Participate in the UBS 2025 Virtual Oncology Day
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CAMBRIDGE, Mass., Sept. 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 that James Porter, Ph.D., Chief Executive Officer, and Alexandra Balcom, Chief Financial Officer, will participa...
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07.09.2025
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Nuvalent Presents Pivotal Data from ARROS-1 Clinical Trial of Zidesamtinib for TKI Pre-treated Patients with Advanced ROS1-positive NSCLC at WCLC 2025
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Rolling NDA submission for zidesamtinib in TKI pre-treated advanced ROS1-positive NSCLC initiated under FDA's RTOR program, with completion on track for the third quarter of 2025
CAMBRIDGE, Mass., Sept. 7, 2025 /PRNewswire/ -- Nuvalent, Inc. (Nasdaq: NUVL), a clinical-stage biopharmaceutical company focused on creating precisely targeted therapie...
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28.08.2025
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Nuvalent to Participate in the Cantor Global Healthcare Conference 2025
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CAMBRIDGE, Mass., Aug. 28, 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., Chief Executive Officer, and Alexandra Balcom, Chief Financial Officer, will participat...
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13.08.2025
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Nuvalent to Present Pivotal Data from ARROS-1 Clinical Trial of Zidesamtinib for TKI Pre-treated Patients with Advanced ROS1-positive NSCLC at WCLC 2025 Presidential Symposium
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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-trea...
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21.07.2025
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Nuvalent Announces Initiation of ALKAZAR Phase 3 Randomized, Controlled Trial Evaluating Neladalkib for Patients with TKI-naïve ALK-positive NSCLC
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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 evalu...
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24.06.2025
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Nuvalent Announces Positive Pivotal Data from ARROS-1 Clinical Trial of Zidesamtinib for TKI Pre-treated Patients with Advanced ROS1-positive NSCLC
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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 2025In 117 ROS1 TKI pre-treated patients, including 50% who had received ≥ 2 p...
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23.06.2025
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Nuvalent Announces Timing of Pivotal Data for TKI Pre-treated Patients with Advanced ROS1-positive NSCLC from ARROS-1 Clinical Trial of Zidesamtinib
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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 an...
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18.06.2025
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Nuvalent Appoints Christy Oliger to Board of Directors
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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....
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08.05.2025
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Nuvalent Outlines Recent Pipeline and Business Progress, Reiterates Key Anticipated Milestones, and Reports First Quarter 2025 Financial Results
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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 nelad...
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29.04.2025
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Nuvalent Announces Publication in Molecular Cancer Therapeutics Reinforcing Rational Molecular Design of Zidesamtinib as a Novel ROS1-Selective Inhibitor
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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 Canc...
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23.04.2025
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Nuvalent to Present Trial in Progress Posters for the ALKAZAR Trial of Neladalkib and HEROEX-1 Trial of NVL-330 at the 2025 American Society of Clinical Oncology Annual Meeting
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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-s...
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01.04.2025
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Nuvalent to Participate in the Stifel 2025 Virtual Targeted Oncology Forum
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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., Chief Executive Officer, and Alexandra Balcom, Chief Financial Officer, will participat...
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25.03.2025
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Nuvalent to Present New Preclinical Data on ALK-Selective Inhibitor, Neladalkib, and ROS1-Selective Inhibitor, Zidesamtinib, at AACR Annual Meeting 2025
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CAMBRIDGE, Mass., March 25, 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 upcoming poster presentations further characterizing the preclinical profiles of its novel ALK-selective inhibit...
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27.02.2025
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Nuvalent Outlines Pipeline and Business Progress, Reiterates Key Anticipated Milestones, and Reports Fourth Quarter and Full Year 2024 Financial Results
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Topline pivotal data expected in 2025 for both TKI pre-treated ROS1-positive and TKI pre-treated ALK-positive NSCLC populations
First NDA submission planned for mid-year 2025 towards potential first approval in 2026 for zidesamtinib in TKI pre-treated ROS1-positive NSCLC population
Development strategies in place for TKI-naïve populations, includ...
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09.12.2024
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Nuvalent Appoints Grant Bogle to Board of Directors
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CAMBRIDGE, Mass., Dec. 9, 2024 /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 Grant Bogle to its Board of Directors....
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26.11.2024
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Nuvalent to Participate in the Piper Sandler 36th Annual Healthcare Conference
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CAMBRIDGE, Mass, Nov. 26, 2024 /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., Chief Executive Officer, and Alexandra Balcom, Chief Financial Officer, will participate...
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12.11.2024
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Nuvalent Highlights Corporate and Pipeline Achievements, Reiterates Key Anticipated Milestones, and Reports Third Quarter 2024 Financial Results
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Achievement of all anticipated 2024 milestones and accelerated development timelines reinforce progress on OnTarget 2026 operating plan towards first approved product in 2026
Leading medical oncologist Alice Shaw, M.D., Ph.D. appointed to Scientific Advisory Board
Strong cash position of $1.2 billion, including proceeds from upsized $575 million...
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18.09.2024
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Nuvalent Announces Closing of Upsized Public Offering of Common Stock
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CAMBRIDGE, Mass., Sept. 18, 2024 /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 closing of its previously announced upsized underwritten public offering of 5,750,000 shares of Class A comm...
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17.09.2024
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Nuvalent Announces Pricing of Upsized Public Offering of Common Stock
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CAMBRIDGE, Mass., Sept. 16, 2024 /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 pricing of an upsized underwritten public offering of 5,000,000 shares of Class A common stock at a price to...
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16.09.2024
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Nuvalent Announces Public Offering of Common Stock
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CAMBRIDGE, Mass., Sept. 16, 2024 /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 it has commenced an underwritten public offering of $350.0 million of its shares of Class A common stock. A...
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14.09.2024
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Nuvalent Highlights Presentation of Clinical Data at ESMO 2024 for Parallel Lead Programs for ROS1 and ALK-positive NSCLC and Accelerated Development Timelines
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Updated Phase 1 dose-escalation data from ARROS-1 and ALKOVE-1 clinical trials continue to support potential best-in-class profiles for zidesamtinib and NVL-655
Rapid enrollment in Phase 2 portions of the ARROS-1 and ALKOVE-1 clinical trials; Pivotal data from both ROS1 and ALK programs now anticipated in 2025
Initiation of ALKAZAR Phase 3 rando...
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13.09.2024
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Nuvalent Announces Publication in Cancer Discovery Detailing Design and Characterization of ALK-selective inhibitor NVL-655
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Publication provides comprehensive assessment of NVL-655's preclinical activity and includes preliminary clinical case studies
CAMBRIDGE, Mass., Sept. 13, 2024 /PRNewswire/ -- Nuvalent, Inc. (Nasdaq: NUVL), a clinical-stage biopharmaceutical company focused on creating precisely targeted therapies for clinically proven kinase targets in cancer, t...
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29.08.2024
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Nuvalent to Participate in the Morgan Stanley 22nd Annual Global Healthcare Conference
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CAMBRIDGE, Mass., Aug. 29, 2024 /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., Chief Executive Officer, and Alexandra Balcom, Chief Financial Officer, will participat...
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08.08.2024
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Nuvalent Highlights Pipeline Progress, Reiterates Key Anticipated Milestones, and Reports Second Quarter 2024 Financial Results
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Company plans to host a conference call in conjunction with oral presentations at ESMO on September 14, 2024, at 8:30 a.m. ET/2:30 p.m. CEST
$658.0 million in cash, cash equivalents and marketable securities expected to support operating runway into 2027
CAMBRIDGE, Mass., Aug. 8, 2024 /PRNewswire/ -- Nuvalent, Inc. (Nasdaq: NUVL), a clinical-stag...
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