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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 the public of $100.00 per share. All shares are being offered by Nuvalent. The gross proceeds to Nuvalent from the offering, before deducting underwriting discount ...

Over the weekend, Nuvalent, Inc. NUVL highlighted the presentation of updated data from Phase 1 doseescalation portions of the ongoing ARROS-1 Phase 1/2 trial of zidesamtinib and ALKOVE-1 Phase 1/2 trial of NVL-655, at the European Society for Medical Oncology (ESMO) Congress 2024. In total, 227 patients were enrolled in the Phase 2 portion of the ARROS-1 trial of zidesamtinib for TKI-naïve and TKI-pretreated patients with advanced ROS1-positive NSCLC and other solid tumors. The company expects to report pi ...

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. All shares are being offered by Nuvalent. The offering is subject to market and other conditions, and there can be no assurance as to whether or when the offering ma ...

Core Insights - Updated Phase 1 dose-escalation data from ARROS-1 and ALKOVE-1 clinical trials support potential best-in-class profiles for zidesamtinib and NVL-655 [1][2] - Rapid enrollment in Phase 2 portions of the ARROS-1 and ALKOVE-1 clinical trials; pivotal data from both ROS1 and ALK programs anticipated in 2025 [1][2] - Initiation of ALKAZAR Phase 3 randomized, controlled trial of NVL-655 for treatment-naïve patients with advanced ALK-positive NSCLC expected in the first half of 2025 [1][2] Company Updates - Nuvalent, Inc. is a clinical-stage biopharmaceutical company focused on creating targeted therapies for kinase targets in cancer [31] - The company has achieved all supporting milestones for 2024 and is on track to share pivotal datasets from both parallel-lead programs in 2025 [4] - The company plans to host a conference call to discuss these updates [24] Clinical Trial Progress - The Phase 2 portion of the ARROS-1 trial has enrolled 227 patients from September 2023 to September 1, 2024, with pivotal data expected in 2025 [2] - The Phase 2 portion of the ALKOVE-1 trial has enrolled 229 patients from February 2024 to September 1, 2024, also with pivotal data expected in 2025 [2] - The ALKAZAR trial is designed to enroll approximately 450 patients with TKI-naïve ALK-positive NSCLC, with primary and secondary endpoints defined [4] Drug Profiles - Zidesamtinib is a novel ROS1-selective inhibitor designed to overcome limitations of existing therapies and has received FDA breakthrough therapy designation [8][26] - NVL-655 is a novel ALK-selective inhibitor with similar design goals and has also received FDA breakthrough therapy designation [18][29] - Both drugs are designed for CNS penetrance and aim to avoid TRK-related adverse events [26][29] Safety and Efficacy Data - Zidesamtinib demonstrated an overall response rate (ORR) of 44% in response-evaluable patients with ROS1-positive NSCLC [9] - NVL-655 showed an ORR of 38% in response-evaluable patients with ALK-positive NSCLC [17] - Both drugs exhibited favorable safety profiles, with no discontinuations due to treatment-related adverse events [11][20]

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, today announced the publication of a manuscript in Cancer Discovery, a journal of the American Association for Cancer Research, which describes the design and charac ...

Updated Phase 1 data from ALKOVE-1 and ARROS-1 clinical trials to be presented at the ESMO Congress 2024 Durable activity of NVL-655 and zidesamtinib in heavily pre-treated patient populations supports ongoing Phase 2 investigation in earlier lines of treatment Company plans to host a conference call on September 14, 2024 at 8:30 a.m. ET/2:30 p.m. CEST following oral presentations at ESMO CAMBRIDGE, Mass., Sept. 9, 2024 /PRNewswire/ -- Nuvalent, Inc. (Nasdaq: NUVL), a clinical-stage biopharmaceutical compan ...

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 participate in a fireside chat during the Morgan Stanley 22nd Annual Global Healthcare Conference on Thursday, September 5, 2024, at 1:05 p.m. ET in NYC. A live webcast will ...

CAMBRIDGE, Mass., July 22, 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 initiation of HEROEX-1, its Phase 1a/1b clinical trial evaluating its novel HER2-selective inhibitor, NVL-330, for pre-treated patients with HER2-altered non-small cell lung cancer (NSCLC). About NVL-330 Nuvalent, Inc. (Nasdaq: NUVL) is a clinical-stage biopharmaceutical c ...

Details for the presentations are as follows: Title: Phase 1/2 ARROS-1 study of zidesamtinib (NVL-520) in ROS1 fusion-positive solid tumors Presentation Number: 1256MO Session Category: Mini oral session Session Title: NSCLC metastatic Presentation Date and Time: Saturday September 14, 2024, 10:30 – 10:35 CEST Location: Santander Auditorium – Hall 5 Presenter: Benjamin Besse, M.D., Ph.D. (Institut Gustav Roussy, Villejuif, France) Title: Profiling of Zidesamtinib and Other ROS1 Inhibitors in an Intracranial ...