JFrog stock rises as Cantor Fitzgerald maintains Overweight rating after strong Q2
CAMBRIDGE - Nuvalent, Inc. (NASDAQ:NUVL), a $5.7 billion market cap biotech company with a robust balance sheet showing 13.5x current assets to liabilities, will present pivotal data for its ROS1-selective inhibitor zidesamtinib at the IASLC 2025 World Conference on Lung Cancer in Barcelona next month, the company announced Wednesday. According to InvestingPro data, the company maintains strong liquidity despite being in the development stage.
The presentation, scheduled for September 7 as part of the Presidential Symposium, will feature results from the global ARROS-1 Phase 1/2 clinical trial in patients with advanced ROS1-positive non-small cell lung cancer (NSCLC) who were previously treated with tyrosine kinase inhibitors (TKIs). Preliminary data for TKI-naïve patients will also be included. Wall Street analysts maintain a Strong Buy consensus on the stock, with price targets ranging from $100 to $140.
Nuvalent has initiated a rolling New Drug Application (NDA) submission for zidesamtinib in TKI pre-treated patients with advanced ROS1-positive NSCLC. The FDA has accepted the application for participation in the Real-Time Oncology Review pilot program, which allows earlier evaluation of efficacy and safety results.
The company expects to complete the NDA submission in the third quarter of 2025.
Zidesamtinib is designed to overcome limitations of current ROS1 inhibitors, including resistance to treatment and inadequate penetration of the central nervous system. The drug has received breakthrough therapy designation for patients with ROS1-positive metastatic NSCLC previously treated with two or more ROS1 tyrosine kinase inhibitors, and orphan drug designation for ROS1-positive NSCLC.
The ARROS-1 trial is a Phase 1/2 clinical study evaluating zidesamtinib in patients with advanced ROS1-positive NSCLC and other solid tumors. The ongoing Phase 2 portion is designed with registrational intent for both TKI-naïve and TKI pre-treated patients.
According to the press release statement, Nuvalent continues to engage with the FDA on potential opportunities for line-agnostic expansion of the drug’s indication. For deeper insights into Nuvalent’s financial health and growth prospects, including 8 additional exclusive ProTips and comprehensive analysis, visit InvestingPro, where you’ll find detailed research reports covering 1,400+ US stocks.
In other recent news, Nuvalent, Inc. has initiated a rolling New Drug Application (NDA) submission for zidesamtinib, a ROS1-selective inhibitor for patients with advanced ROS1-positive non-small cell lung cancer. The FDA has accepted the application for the Real-Time Oncology Review pilot program, enabling earlier evaluation of efficacy and safety results. Additionally, Nuvalent has begun the ALKAZAR Phase 3 clinical trial for neladalkib, aimed at treating patients with advanced ALK-positive non-small cell lung cancer who have not previously received tyrosine kinase inhibitor treatment. The trial will compare neladalkib to ALECENSA, a current standard of care, with plans to enroll approximately 450 patients.
In the realm of analyst ratings, Goldman Sachs has initiated coverage on Nuvalent with a Buy rating and 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. Furthermore, UBS has raised its price target for Nuvalent to $114 from $100, maintaining a Buy rating. This adjustment follows the release of pivotal Phase 2 ARROS-1 data, which highlighted the drug’s superior performance compared to existing therapies. These developments indicate growing confidence in Nuvalent’s drug pipeline and its potential impact on lung cancer treatment.
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