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."Christy's proven success in delivering new therapies to patients living with cancer strengthens our Board as we evolve from a development-stage company toward potential commercialization," said James Porter, Ph.D., C ...

纪要涉及的公司和行业 - 公司：Nuvalent (NUVL) - 行业：肿瘤学，具体涉及ROS1、ALK、HER2 exon 20相关的非小细胞肺癌治疗领域 纪要提到的核心观点和论据 ROS1项目 - **数据披露计划**：计划在今年上半年以独立新闻稿形式公布TKI预处理ROS1患者的关键顶线数据，并在未来医学会议上分享完整数据[4] - **zidosanthanib优势**：现有ROS1治疗药物crizotinib存在脑穿透性有限和ROS1突变等局限性，其他药物为双TRK ROS1抑制剂，会带来认知或CNS不良事件；zidosanthanib可进入大脑，治疗ROS1耐药突变，且对ROS1有选择性，能避免TRK抑制带来的不良事件，有望成为下一代ROS1 TKI[5] - **临床试验情况**：二期试验纳入TKI初治和既往治疗过的ROS1非小细胞肺癌患者，截至去年12月共招募430名患者，其中330名进入二期；试验纳入标准宽松，将分析不同治疗史、疾病阶段、是否有脑转移和ROS1耐药突变等患者的数据[6][10][11] - **数据评估**：一期数据是评估二期数据的基准，二期将采用更严格的盲法独立中心审查；难以预测盲法中心审查对缓解率基线预期的影响[15][17][18] - **商业机会**：crizotinib年销售额约4亿美元，主要来自ROS1领域，但存在局限性；zidosanthanib能解决这些问题，有望改变ROS1治疗模式，创造商业机会[33][35] ALK项目 - **市场需求和策略**：ALK领域有六种获批疗法，一线标准治疗药物是alectinib，仅lorlatinib能在alectinib治疗进展后发挥作用，但患者进展到三线时无有效药物；neledalco旨在开发能在三线治疗中对ALK单突变和复合突变有效的药物，同时具备良好的CNS活性，且避免TRK抑制带来的不良事件[43][44][45] - **临床试验情况**：二期试验有二线和三线队列，纳入任何ALK肺癌患者；三线治疗无有效药物，公司在此有突破性认定，一期试验中约三分之一以上患者有反应且反应持久；二线治疗中lorlatinib缓解率为31 - 39%，缓解持续时间约七个月，公司希望在二期试验中展示比lorlatinib更持久的缓解[48][49][50][52] HER2 exon 20项目 - **未满足的需求**：HER2肺癌的驱动因素是HER2 exon 20，一些HER2药物用于HER2肺癌治疗效果不佳，原因是对exon 20的抑制指数不如野生型EGFR，会导致皮肤和胃肠道毒性，患者难以持续治疗；需要开发对exon 20抑制指数高且脑穿透性强的药物[63][64] - **项目进展**：NVL 330在临床前试验中脑穿透性良好，目前正在进行剂量递增试验，尚未确定公布数据的时间[66][67] 其他重要但是可能被忽略的内容 - **监管和审批**：公司计划在获得顶线数据后将其纳入新药申请（NDA）提交，此前已开展非临床表征、制造和质量等方面的工作；对于ROS1项目，不确定监管审查流程；对于ALK项目，计划今年晚些时候获得二线和三线数据[21][24][55] - **突破指定**：ROS1项目在后期治疗中有突破指定，未来是否寻求一线突破指定将根据数据和与监管机构的沟通情况决定；ALK项目在三线治疗中有突破指定[29][50] - **定价**：目前处于生成关键数据阶段，暂不适合评论zidosanthanib的定价，未来会参考先例进行考虑[40]

(Mark One) Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 10-Q ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended March 31, 2025 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from _____________ to _____________ Commission File Number: 001-40671 NUVALENT, INC. (Exact name of registrant as specified in its charter) Delaw ...

Exhibit 99.1 Nuvalent Outlines Recent Pipeline and Business Progress, Reiterates Key Anticipated Milestones, and Reports First Quarter 2025 Financial Results 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 i ...

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 2025Pivotal data for neladalkib in TKI pre-treated ALK-positive NSCLC population anticipated by year-end 2025Strengthened leadership team with key internal promotionsCAMBRIDGE, Mass., May 8, 2 ...

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. Zidesamtinib is currently being evaluated in the ...

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. Posters will be archive ...

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 ...

文章核心观点 - 临床阶段生物制药公司Nuvalent宣布将在2025年美国癌症研究协会年会上展示新型ALK选择性抑制剂neladalkib和新型ROS1选择性抑制剂zidesamtinib的临床前特征海报 [1] 公司信息 - Nuvalent是临床阶段生物制药公司，专注为癌症患者开发精准靶向疗法，利用化学和基于结构的药物设计专业知识开发创新小分子，有针对ROS1阳性、ALK阳性和HER2改变的非小细胞肺癌的候选药物及多个发现阶段研究项目 [5][6] 海报展示信息 neladalkib海报 - 标题为“Mutagenesis screens support potential best - in - class profile for neladalkib (NVL - 655), a brain - penetrant and TRK - sparing ALK inhibitor” - 作者为Anupong Tangpeerachaikul、Henry E. Pelish - 摘要编号1729 - 会议类别为Experimental and Molecular Therapeutics - 会议标题为Kinase and Phosphatase Inhibitors 1 - 会议日期和时间为2025年4月28日上午9:00 - 12:00 CT - 地点为Poster Section 21 - 海报板编号4 [2] zidesamtinib海报 - 标题为“Crystal structure of drug - resistant ROS1 G2032R in complex with zidesamtinib, a clinical - stage ROS1 inhibitor with best - in - class potential” - 作者为Joseph M. Magrino、Anupong Tangpeerachaikul、Scot Mente、Henry E. Pelish - 摘要编号5616 - 会议类别为Experimental and Molecular Therapeutics - 会议标题为Kinase and Phosphatase Inhibitors 3 - 会议日期和时间为2025年4月29日下午2:00 - 5:00 CT - 地点为Poster Section 20 - 海报板编号26 [2] 药物信息 zidesamtinib - 是新型脑渗透ROS1选择性抑制剂，旨在克服现有ROS1抑制剂局限性，对耐药肿瘤保持活性，可穿透中枢神经系统，避免抑制TRK家族，避免TRK相关中枢神经系统不良事件，已获ROS1阳性转移性非小细胞肺癌突破性疗法认定和孤儿药认定 [3] neladalkib - 是新型脑渗透ALK选择性抑制剂，旨在克服现有ALK抑制剂局限性，对耐药肿瘤保持活性，可穿透中枢神经系统，避免抑制TRK家族，避免TRK相关中枢神经系统不良事件，已获ALK阳性非小细胞肺癌突破性疗法认定和孤儿药认定 [4]

文章核心观点 Nuvalent公司宣布其首席执行官和首席财务官将参加3月的投资者会议，会议网络直播将在公司网站提供并存档30天 [1] 公司介绍 - Nuvalent是临床阶段生物制药公司，专注为癌症患者开发精准靶向疗法，克服现有激酶靶点疗法局限 [2] - 公司利用化学和基于结构的药物设计专业知识，开发创新小分子，有克服耐药性、减少不良事件、解决脑转移和推动更持久反应的潜力 [2] - 公司推进强大产品线，有针对ROS1阳性、ALK阳性和HER2改变的非小细胞肺癌的研究候选药物，还有多个发现阶段研究项目 [2] 会议信息 - 公司首席执行官和首席财务官将参加3月的三场投资者会议，分别是3月5日上午9:50在波士顿举行的TD Cowen第45届年度医疗保健会议、3月10日上午10:40在佛罗里达州迈阿密举行的Leerink 2025全球医疗保健会议、3月12日下午2:30在佛罗里达州迈阿密举行的巴克莱第27届年度全球医疗保健会议 [1][4] - 会议网络直播将在公司网站投资者板块提供，并在演示后存档30天 [1]