Core Insights - Nuvalent, Inc. announced preliminary data from the ALKOVE-1 Phase 1/2 clinical trial of neladalkib, an investigational ALK-selective inhibitor, showing encouraging activity in advanced ALK-positive solid tumors beyond non-small cell lung cancer (NSCLC) [1][2] Group 1: Clinical Trial Data - The ALKOVE-1 trial is currently enrolling adult and adolescent patients with advanced ALK-positive solid tumors beyond NSCLC, with preliminary data reported for 34 response-evaluable patients across 14 solid tumor types [1][2] - An objective response rate of 44% was observed among all patients treated with neladalkib, with 80% of responders remaining on treatment without disease progression as of the data cutoff date [3] - The majority of patients (32 out of 34) received the recommended Phase 2 dose of 150 mg once daily, with 38% being ALK TKI-naïve and 62% ALK TKI pre-treated [2][3] Group 2: Safety and Efficacy - Neladalkib was generally well-tolerated, with low rates of dose reduction (8.8%) and no discontinuations due to treatment-related adverse events reported [3] - The safety profile aligns with its ALK-selective, TRK-sparing design, indicating potential advantages over existing therapies [3][7] Group 3: Future Developments - The company is on track to report topline data for TKI pre-treated ALK-positive NSCLC patients by the end of 2025 and is also evaluating neladalkib in the ALKAZAR Phase 3 trial for TKI-naïve ALK-positive NSCLC [4][8] - The ongoing global Phase 2 cohort of the ALKOVE-1 trial aims to further explore the efficacy of neladalkib in a broader patient population [4]

SOURCE Nuvalent, Inc. WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? Details of the poster presentation are as follows: Title:Â Preclinical intracranial activity of NVL-330, a selective HER2 tyrosine kinase inhibitor Abstract Number: B057 Authors:Â Yuting Sun*, Kristin L. Andrews, Anupong Tangpeerachaikul, Michael J. Walsh, Nancy E. Kohl, Joshua C. Horan, Henry E. PelishSession: Poster Session B Session Date and Time:Â Friday, October 24, 2025, 12:30-4:00 p.m. ET Location: Exhibit Hall D *Presenter, c ...

Core Insights - Nuvalent, Inc. announced pivotal data for zidesamtinib, a novel ROS1-selective inhibitor, targeting advanced ROS1-positive non-small cell lung cancer (NSCLC) patients, which will be presented at the IASLC 2025 World Conference on Lung Cancer [1][2] - The company has initiated a rolling NDA submission for zidesamtinib, with the FDA agreeing to accept the NDA for the Real-Time Oncology Review pilot program, aiming for completion in Q3 2025 [2][3] Company Overview - Nuvalent, Inc. is a clinical-stage biopharmaceutical company focused on developing targeted therapies for cancer, specifically for clinically proven kinase targets [5][6] - The company leverages expertise in chemistry and structure-based drug design to create innovative small molecules that address treatment resistance and minimize adverse events [6] Product Details - Zidesamtinib is designed to be a brain-penetrant ROS1-selective inhibitor, effective against tumors that have developed resistance to existing ROS1 inhibitors, including those with treatment-emergent mutations [3][4] - The ARROS-1 Phase 1/2 clinical trial is investigating zidesamtinib in patients with advanced ROS1-positive NSCLC, with the Phase 1 portion focusing on safety and tolerability [4]

Core Viewpoint - Nuvalent, Inc. is set to discuss pivotal data for zidesamtinib, a novel ROS1-selective inhibitor, in a conference call on June 24, 2025, focusing on its application in advanced ROS1-positive non-small cell lung cancer patients [1] Group 1: Company Overview - Nuvalent, Inc. is a clinical-stage biopharmaceutical company dedicated to developing targeted therapies for cancer, specifically aimed at overcoming limitations of existing treatments for kinase targets [5] - The company is advancing a robust pipeline that includes investigational candidates for ROS1-positive, ALK-positive, and HER2-altered non-small cell lung cancer, along with multiple discovery-stage research programs [5] Group 2: Zidesamtinib and Clinical Trials - Zidesamtinib is designed to be a brain-penetrant ROS1-selective inhibitor, addressing resistance seen with current ROS1 inhibitors and targeting tumors with treatment-emergent ROS1 mutations [3] - The ARROS-1 trial is a first-in-human Phase 1/2 clinical trial evaluating zidesamtinib in patients with advanced ROS1-positive non-small cell lung cancer and other solid tumors, focusing on safety, tolerability, and preliminary anti-tumor activity [4] - Zidesamtinib has received breakthrough therapy designation for ROS1-positive metastatic non-small cell lung cancer patients previously treated with two or more ROS1 tyrosine kinase inhibitors, as well as orphan drug designation for ROS1-positive NSCLC [3]

Core Insights - Nuvalent, Inc. is focused on advancing its pipeline of targeted therapies for cancer, with pivotal data for zidesamtinib and neladalkib expected in 2025 to support New Drug Application submissions [1][2][5] Pipeline and Business Highlights - The company anticipates pivotal data for zidesamtinib in TKI pre-treated ROS1-positive NSCLC in the first half of 2025, with an NDA submission expected by mid-2025 [1][5] - The ALKAZAR Phase 3 trial for neladalkib is set to begin in the first half of 2025, targeting front-line ALK-positive NSCLC [1][6] - Pivotal data for neladalkib in TKI pre-treated ALK-positive NSCLC is expected by the end of 2025 [1][5] Leadership Promotions - Nuvalent has strengthened its leadership team with key promotions: Ruth Adams to Senior Vice President of Clinical Operations, Dr. Joshua Horan to Senior Vice President of Chemistry, and Jessie Lin to Senior Vice President of Corporate Strategy and Portfolio Management [2][12] Financial Results - As of March 31, 2025, the company reported cash, cash equivalents, and marketable securities totaling $1.1 billion, sufficient to fund operations into 2028 [13][19] - Research and development expenses for Q1 2025 were $74.4 million, while general and administrative expenses were $20.4 million, resulting in a net loss of $84.6 million for the quarter [13][18]

Core Insights - Nuvalent, Inc. is presenting two "Trial in Progress" posters for its novel ALK-selective inhibitor neladalkib and HER2-selective inhibitor NVL-330 at the 2025 ASCO Annual Meeting [1][2][3] Group 1: Neladalkib - Neladalkib is being evaluated in the ALKAZAR Phase 3 trial, which is a global, randomized, controlled study comparing neladalkib to ALECENSA® for TKI-naïve ALK-positive non-small cell lung cancer (NSCLC) [2][4] - The ALKAZAR trial is set to initiate in the first half of 2025, with a 1:1 randomization for patients to receive either neladalkib monotherapy or ALECENSA® monotherapy [2] - Neladalkib is designed to penetrate the brain and remain effective against tumors that have developed resistance to existing ALK inhibitors, including those with specific mutations [4][6] Group 2: NVL-330 - NVL-330 is currently being assessed in the HEROEX-1 Phase 1a/1b clinical trial, focusing on safety and tolerability for pre-treated patients with HER2-altered NSCLC [3][5] - The trial aims to determine the recommended Phase 2 dose and evaluate the pharmacokinetic profile and preliminary anti-tumor activity of NVL-330 [3] - NVL-330 is designed to treat HER2-mutant tumors while minimizing adverse events related to off-target inhibition of wild-type EGFR and addressing brain metastases [5][6] Group 3: Company Overview - Nuvalent, Inc. is a clinical-stage biopharmaceutical company focused on developing targeted therapies for cancer, aiming to overcome limitations of existing treatments [6] - The company is advancing a robust pipeline that includes investigational candidates for ROS1-positive, ALK-positive, and HER2-altered NSCLC, along with multiple discovery-stage research programs [6]