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Nuvalent , Inc. (NASDAQ:NUVL), a $6 billion market cap biotechnology company with strong liquidity metrics, announced Monday the initiation of ALKAZAR, its Phase 3 clinical trial evaluating neladalkib for patients with advanced ALK-positive non-small cell lung cancer who have not previously received tyrosine kinase inhibitor (TKI) treatment. According to InvestingPro data, the company maintains a healthy balance sheet with more cash than debt and a robust current ratio of 14.5x. The study will compare neladalkib to ALECENSA, a current front-line standard of care, with the first patient having been dosed in the trial.
The information is based on a statement from a company press release filed with the Securities and Exchange Commission.
In other recent news, Nuvalent, Inc. has dosed the first patient in its global Phase 3 trial for the lung cancer drug neladalkib, targeting ALK-positive non-small cell lung cancer (NSCLC). The trial, known as ALKAZAR, will compare neladalkib to alectinib, enrolling approximately 450 patients. In another significant development, Goldman Sachs initiated coverage on Nuvalent with a Buy rating, citing the promising results of zidesamtinib in Phase 2 trials for ROS1+ NSCLC patients. UBS also raised its price target for Nuvalent to $114, maintaining a Buy rating, and highlighted the superior performance of zidesamtinib in clinical trials. Nuvalent plans to submit a New Drug Application for zidesamtinib to the FDA in July 2025, with the application process expected to conclude by the third quarter of that year. The drug has shown strong results in previously treated patients, with a 44% objective response rate and significant durability. Additionally, Nuvalent has appointed Christy Oliger, a former Genentech executive, to its Board of Directors, bringing extensive experience to the company as it progresses towards potential commercialization of its therapies.
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