Bill Gross warns on gold momentum as regional bank stocks tumble
Investing.com - Nuvation Bio Inc (NYSE:NUVB), a $1.1 billion market cap biotech company that has seen its shares surge over 70% in the past six months, received regulatory approval from Japan’s Ministry of Health, Labour and Welfare (MHLW) for IBTROZI (taletrectinib) to treat adult patients with ROS1-positive unresectable, advanced and/or recurrent non-small cell lung cancer.
The approval, announced on September 19, enables Nippon Kayaku to commercialize IBTROZI in Japan under an exclusive license agreement established in 2023. Nuvation Bio will receive royalties based on net sales in Japan, with a $25 million milestone payment expected next quarter upon establishment of the reimbursement price. According to InvestingPro data, the company maintains a strong financial position with more cash than debt and a healthy current ratio of 9.39x.
The MHLW based its decision on data from the pivotal Phase 2 TRUST clinical program, which evaluated taletrectinib in patients globally, including Japan. Results from a pooled analysis of the program were published in the Journal of Clinical Oncology in April 2025.
The Japanese regulator also approved the AmoyDx PLC Panel as a companion diagnostic to identify patients with locally advanced or metastatic ROS1+ NSCLC who may benefit from IBTROZI treatment.
Taletrectinib is already approved in the United States under the IBTROZI brand name and in China as DOVBLERON. H.C. Wainwright maintained its Buy rating and $10.00 price target on Nuvation Bio following the announcement. Analyst consensus remains strongly bullish, with targets ranging from $6 to $10. Get deeper insights and access to 8 additional exclusive InvestingPro Tips, plus comprehensive financial analysis in our Pro Research Report.
In other recent news, Nuvation Bio Inc. reported its second-quarter earnings for 2025, meeting expectations with an earnings per share (EPS) of -$0.17. The company’s revenue significantly exceeded forecasts, reaching $4.8 million compared to the anticipated $416,670. Additionally, Japan’s Ministry of Health, Labour and Welfare approved Nuvation Bio’s cancer drug IBTROZI for treating ROS1-positive unresectable, advanced, and/or recurrent non-small cell lung cancer. Nippon Kayaku will handle the drug’s commercialization in Japan under an exclusive license agreement. This approval follows similar regulatory clearances in the United States and China earlier this year. Furthermore, H.C. Wainwright has reiterated its Buy rating for Nuvation Bio with a $10 price target, citing potential market opportunities for IBTROZI. The firm also highlighted Nuvation’s initiation of a new Phase 3 trial, TRUST-IV, for IBTROZI as an adjuvant therapy for certain lung cancer patients. These developments reflect ongoing progress and interest in Nuvation Bio’s initiatives.
This article was generated with the support of AI and reviewed by an editor. For more information see our T&C.