财务状况 - 公司现金、现金等价物和可流通证券为6.58亿美元，预计可支持运营至2027年[4][15] - 研发费用为4,920万美元[16] - 一般及行政费用为1,600万美元[17] - 净亏损为5,720万美元[17] 临床试验进展 - 公司计划在2024年9月14日ESMO大会上提供ARROS-1和ALKOVE-1临床试验的最新进展情况[8][10] - 公司获得FDA突破性疗法认定用于治疗既往接受两种或更多ALK酪氨酸激酶抑制剂的局部晚期或转移性ALK阳性非小细胞肺癌患者[9] - 公司正在推进HEROEX-1 I期临床试验,评估NVL-330用于预治疗HER2改变的非小细胞肺癌患者[12] 未来发展计划 - 公司计划在2024年推出ALK项目的前线开发策略[9] - 公司制定了OnTarget 2026三年运营计划,预计在2025年获得首个潜在的关键性数据,2026年获得首个潜在批准产品[18][19][20]

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)."HER2 alterations are an important category of oncogenic drivers within NSCLC that i ...

CAMBRIDGE, Mass., July 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 updated data from the ARROS-1 Phase 1/2 clinical trial of zidesamtinib and ALKOVE-1 Phase 1/2 clinical trial of NVL-655, will be presented during two oral presentations at the European Society for Medical Oncology (ESMO) Congress 2024 taking place September 13-17, 2024, i ...

CAMBRIDGE, Mass., July 11, 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 Henry Pelish, Ph.D., has been promoted to Chief Scientific Officer. In this role, Dr. Pelish will continue to oversee discovery and early-stage development activities."This promotion reflects Henry's significant contributions to establishing the cornerstone of our approac ...

Nemes Laszlo Nuvalent (NASDAQ:NUVL) recently publicized that the FDA gave NVL-655 their Breakthrough Therapy Designation (BTD) for locally advanced or metastatic ALK+ non-small cell lung cancer (NSCLC). The BTD press release encouraged me to do some preliminary research on Nuvalent and NVL-655. It didn't take me long to determine that NVL-655 has the potential to be a vital therapy for ALK+ NSCLC patients who often have to deal with multiple lines of therapy after their cancer develops resistance to targete ...

CAMBRIDGE, Mass., May 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 2024 Jefferies Global Healthcare Conference on Wednesday, June 5, 2024, at 4:30 p.m. ET in NYC. A live webcast will be available in t ...

CAMBRIDGE, Mass., May 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 the U.S. Food and Drug Administration (FDA) has granted breakthrough therapy designation (BTD) to NVL-655 for the treatment of patients with locally advanced or metastatic ALK- positive non-small cell lung cancer (NSCLC) who have been previously treated with two or more AL ...

Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended March 31, 2024 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) Delawar ...

Exhibit 99.1 Nuvalent Highlights Pipeline Progress, Reiterates Key Anticipated Milestones, and Reports First Quarter 2024 Financial Results Updates from the ongoing Phase 1/2 ARROS-1 and ALKOVE-1 clinical trials expected at a medical meeting in the second half of 2024 Strong financial position with operating runway anticipated into 2027 CAMBRIDGE, Mass. — May 9, 2024 — Nuvalent, Inc. (Nasdaq: NUVL), a clinical-stage biopharmaceutical company focused on creating precisely targeted therapies for clinically pr ...

Investors are always looking for stocks that are poised to beat at earnings season and Nuvalent, Inc. (NUVL) may be one such company. The firm has earnings coming up pretty soon, and events are shaping up quite nicely for their report. That is because Nuvalent is seeing favorable earnings estimate revision activity as of late, which is generally a precursor to an earnings beat. After all, analysts raising estimates right before earnings — with the most up-to- date information possible — is a pretty good ind ...