Nuvalent initiates rolling NDA submission for ROS1-positive NSCLC drug

CAMBRIDGE, Mass. - Nuvalent, Inc. (NASDAQ:NUVL), a clinical-stage biopharmaceutical company with a market capitalization of $5.5 billion, has initiated a rolling New Drug Application (NDA) submission for zidesamtinib, its ROS1-selective inhibitor for previously treated patients with advanced ROS1-positive non-small cell lung cancer (NSCLC), the company announced Thursday.

The biopharmaceutical firm aims to complete the submission in the third quarter of 2025. The FDA has accepted the application for participation in the Real-Time Oncology Review pilot program, which allows earlier evaluation of topline efficacy and safety results.

In parallel, Nuvalent has begun the ALKAZAR Phase 3 randomized trial of neladalkib for front-line ALK-positive NSCLC. The study will compare neladalkib monotherapy against alectinib, a current standard of care, with patients randomized in a 1:1 ratio.

The company expects to report topline pivotal data for neladalkib in previously treated patients with ALK-positive NSCLC by year-end 2025. Preliminary data for neladalkib in patients with ALK-positive solid tumors beyond NSCLC will be presented at the European Society for Medical Oncology Congress in October 2025.

Nuvalent also announced the promotion of Jason Waters to Senior Vice President, Commercial. Waters brings over 20 years of pharmaceutical experience, including commercial oncology roles at Mersana Therapeutics, GSK, TESARO, and Takeda Oncology. With analyst consensus showing a strong buy recommendation and price targets ranging from $100 to $140, the company appears well-positioned for its commercial expansion. For deeper insights into Nuvalent’s valuation and growth prospects, investors can access comprehensive analysis through InvestingPro’s detailed research reports.

The company reported cash, cash equivalents, and marketable securities of $1.0 billion as of June 30, 2025, which it believes will fund operations into 2028. According to InvestingPro data, Nuvalent maintains a strong financial position with a current ratio of 14.48, indicating robust liquidity. For the second quarter, Nuvalent posted a net loss of $99.7 million, with research and development expenses of $80.9 million and general and administrative expenses of $23.7 million.

This article is based on a press release statement from Nuvalent. InvestingPro analysis reveals additional insights about Nuvalent’s financial health, including its strong cash position and liquid assets exceeding short-term obligations. InvestingPro subscribers have access to 10 more exclusive ProTips and comprehensive financial metrics to make informed investment decisions.

In other recent news, Nuvalent, Inc. has initiated a Phase 3 clinical trial named ALKAZAR, focusing on neladalkib for patients with advanced ALK-positive non-small cell lung cancer. The trial, which has already dosed its first patient, will compare neladalkib to alectinib, a current standard treatment, and aims to enroll approximately 450 patients. In addition, Goldman Sachs has begun coverage of Nuvalent with a Buy rating, setting a price target of $105. This decision was influenced by the promising Phase 2 ARROS-1 results for zidesamtinib in TKI pre-treated ROS1+ NSCLC patients. UBS also raised its price target for Nuvalent to $114, maintaining a Buy rating, following the same pivotal Phase 2 data showing superior efficacy of zidesamtinib. Furthermore, Nuvalent plans to submit a New Drug Application for zidesamtinib in July 2025, having reached an agreement with the FDA on the submission strategy. The company will participate in the Real-Time Oncology Review program, with a target completion in the third quarter of 2025. These developments highlight significant progress in Nuvalent’s efforts in advancing treatments for lung cancer.

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