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]

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 participate in a fireside chat during the Stifel 2025 Virtual Targeted Oncology Forum on Tuesday, April 8, 2025, at 2:30 p.m. ET. A live webcast will be available in the Inve ...

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 inhibitor, neladalkib, and novel ROS1-selective inhibitor, zidesamtinib, at the American Association for Cancer Research (AACR) Annual Meeting 2025 from April 25-30, 2025, ...

CAMBRIDGE, Mass., Feb. 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 participate in fireside chats during the following March investor conferences: TD Cowen 45th Annual Health Care Conference on Wednesday, March 5, 2025 at 9:50 a.m. ET in Bos ...

Table of Contents Commission file number: 001-40671 _____________________________________________________ NUVALENT, INC. UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 _____________________________________________________ FORM 10-K _____________________________________________________ (Mark One) ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2024 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF T ...

Exhibit 99.1 Nuvalent Outlines Pipeline and Business Progress, Reiterates Key Anticipated Milestones, and Reports Fourth Quarter and Full Year 2024 Financial Results 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, incl ...

Topline pivotal data expected in 2025 for both TKI pre-treated ROS1-positive and TKI pre-treated ALK-positive NSCLC populationsFirst NDA submission planned for mid-year 2025 towards potential first approval in 2026 for zidesamtinib in TKI pre-treated ROS1-positive NSCLC populationDevelopment strategies in place for TKI-naïve populations, including planned initiation of ALKAZAR Phase 3 randomized, controlled trial of neladalkib for front-line ALK-positive NSCLC in first half of 2025Implemented global Expande ...

Strategy prioritizes most accelerated path to first potential approval  Initial NDA submission expected by mid-year for zidesamtinib in TKI pre-treated ROS1-positive NSCLC population, with topline pivotal data anticipated in the first half of 2025 Topline pivotal data for neladalkib (NVL-655) in TKI pre-treated ALK-positive NSCLC population anticipated by year-end 2025 Company to present at 43rd Annual J.P. Morgan Healthcare Conference on Tuesday, January 14th at 9:00 a.m. PT CAMBRIDGE, Mass., Jan. 13, 2025 ...

Investment Opportunities - Nuvalent's ALK-selective inhibitor, NVL-655, has been granted Breakthrough Therapy Designation (BTD) by the FDA, indicating its potential as a blockbuster therapy [2] - The company focuses on innovative therapies and pharmaceuticals with catalysts for potential acquisitions, particularly in the biotech and life-saving therapies sector [2] Analyst's Position - The analyst holds a beneficial long position in Nuvalent (NUVL) and several other pharmaceutical companies, including Pfizer (PFE), Eli Lilly (LLY), AstraZeneca (AZN), Takeda (TAK), Merck (MRK), Roche (RHHBY), Johnson & Johnson (JNJ), Amgen (AMGN), and Bristol-Myers Squibb (BMY) [3] Disclosure - The article is written by the analyst and reflects their personal opinions, with no compensation received other than from Seeking Alpha [3] - Seeking Alpha clarifies that its analysts are third-party authors, including both professional and individual investors, and the platform is not a licensed securities dealer, broker, or investment adviser [4]

CAMBRIDGE, Mass., Dec. 19, 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, will present at the 43rd Annual J.P. Morgan Healthcare Conference on Tuesday, January 14, 2025, at 9:00 a.m. PT in San Francisco.  A live webcast will be available in the Investors section of the company's website at www.nuval ...