Nuvalent Announces Corporate Updates and Anticipated Milestones for 2025

On January 13, 2025, Nuvalent, Inc. (NASDAQ: NUVL) released a press release detailing strategic initiatives towards achieving its first potential approval in 2026 and outlining key milestones expected in 2025. The company is a clinical-stage biopharmaceutical entity dedicated to developing precision-targeted therapies for proven kinase targets in cancer.

Under the “OnTarget 2026” operating plan, Nuvalent disclosed various achievements projected for 2025, including the submission of an initial New Drug Application (NDA) for zidesamtinib in TKI pre-treated ROS1-positive NSCLC patients by mid-year 2025. Pivotal trial data for zidesamtinib and neladalkib (NVL-655) in ALK-positive NSCLC pre-treated patients are anticipated in the first half and by year-end 2025, respectively.

Nuvalent also plans to commence the ALKAZAR Phase 3 study for TKI-naïve patients with ALK-positive NSCLC in the first half of 2025 and continue progressing the HEROEX-1 Phase 1a/1b trial targeting patients with advanced HER2-altered NSCLC.

The company foresees its first potential approval in 2026 with zidesamtinib for treating TKI pre-treated ROS1-positive NSCLC. Nuvalent’s CEO, James Porter, highlighted their commitment to patients and healthcare professionals supporting their clinical endeavors, emphasizing the urgency of providing new treatment alternatives quickly.

Darlene Noci, Nuvalent’s Chief Development Officer, echoed the sentiment, illustrating the parallel development pathways in place aiming to deliver new treatment options for all ROS1- or ALK-positive NSCLC patients. The company’s strategic plans involve NDA submissions and topline pivotal data presentations for zidesamtinib and neladalkib throughout 2025.

Financially, Nuvalent, under the guidance of CFO Alexandra Balcom, expressed confidence in their team and financial backing, extending runway support until 2028. The firm remains steadfast in its commitment to advancing clinical programs and ongoing research for sustained growth.

Enrollment updates for key trials, ARROS-1 and ALKOVE-1, focusing on ROS1-positive and ALK-positive NSCLC patients respectively, were also highlighted. Dr. Porter will present these developments at the 43rd Annual J.P. Morgan Healthcare Conference on January 14, 2025.

Nuvalent underscores its mission as a pioneer in creating tailored therapies for cancer patients, leveraging innovative drug design to conquer treatment limitations and optimize patient outcomes. However, with drug development inherently risky, Nuvalent acknowledges potential challenges and emphasizes transparent communication regarding its progress and any anticipated setbacks.

Investor and media inquiries can be directed to Chelcie Lister at Nuvalent, Inc. ([email protected]) and Josie Butler at 1AB ([email protected]), respectively.

This article is based on the information provided in Nuvalent’s 8-K filing dated January 13, 2025, and the accompanying press release exhibit 99.1.

This article was generated by an automated content engine and was reviewed by a human editor prior to publication. For additional information, read Nuvalent’s 8K filing here.

About Nuvalent

Nuvalent, Inc, a clinical stage biopharmaceutical company, engages in the development of therapies for patients with cancer. Its lead product candidates are NVL-520, a novel ROS1-selective inhibitor to address the clinical challenges of emergent treatment resistance, central nervous system (CNS)-related adverse events, and brain metastases that may limit the use of ROS1 tyrosine kinase inhibitors (TKIs) for patients with ROS proto-oncogene 1 (ROS1)-positive non-small cell lung cancer (NSCLC) which is under the phase 2 portion of the ARROS-1 Phase 1/2 clinical trial; NVL-655, a brain-penetrant ALK-selective inhibitor, to address the clinical challenges of emergent treatment resistance, CNS-related adverse events, and brain metastases that might limit the use of first-, second-, and third-generation ALK inhibitors that is under the phase 2 portion of the ALKOVE-1 Phase 1/2 clinical trial; and NVL-330, a brain-penetrant human epidermal growth factor receptor 2 (HER2)-selective inhibitor designed to treat tumors driven by HER2ex20, brain metastases, and avoiding treatment-limiting adverse events including due to off-target inhibition of wild-type EGFR, which is expected to initiate phase 1 trial.