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Nuvalent, Inc. (NASDAQ:NUVL), a $5.5 billion market cap biotech company currently trading at $76.67, announced Monday the completion of its New Drug Application (NDA) submission to the U.S. Food and Drug Administration for zidesamtinib. The application covers use of the drug in tyrosine kinase inhibitor pre-treated patients with advanced ROS1-positive non-small cell lung cancer. According to InvestingPro data, analysts maintain a bullish outlook on the stock, with price targets ranging from $100 to $140.
The company, headquartered in Cambridge, Massachusetts, disclosed the development in a statement included in a filing with the Securities and Exchange Commission.
Nuvalent’s Class A common stock is listed on the Nasdaq Global Select Market under the symbol NUVL.
The information in this article is based on a press release statement filed with the SEC.
In other recent news, Nuvalent , Inc. has initiated a rolling New Drug Application (NDA) submission for its ROS1-selective inhibitor, zidesamtinib, targeting advanced ROS1-positive non-small cell lung cancer (NSCLC). The submission is expected to be completed in the third quarter of 2025, and the FDA has accepted it for the Real-Time Oncology Review pilot program, potentially expediting the review process. Nuvalent has also announced the start of its Phase 3 trial, ALKAZAR, for neladalkib in ALK-positive lung cancer patients, comparing it to the existing standard of care, ALECENSA. The company will present pivotal data for zidesamtinib at the IASLC 2025 World Conference on Lung Cancer next month, showcasing results from the ARROS-1 Phase 1/2 clinical trial. On the analyst front, Guggenheim initiated coverage on Nuvalent with a Buy rating and a $122.00 price target, citing the company’s potential in the lung cancer treatment market. Piper Sandler also began coverage with an Overweight rating and a $112.00 price target, noting the potential for near-term value creation. Both firms highlight Nuvalent’s promising prospects in the precision oncology field.
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