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TOKYO - Japan’s Ministry of Health, Labour and Welfare (MHLW) has approved IBTROZI (taletrectinib) for the treatment of adult patients with ROS1-positive unresectable, advanced and/or recurrent non-small cell lung cancer (NSCLC), Nuvation Bio Inc. (NYSE:NUVB) announced Thursday. The clinical-stage biopharmaceutical company, currently valued at $1.09 billion, has seen impressive momentum with its stock surging 60% over the past six months, according to InvestingPro data.
Nippon Kayaku will commercialize the drug in Japan under an exclusive license agreement entered in 2023. The approval follows similar regulatory clearances in the United States and China earlier this year.
The Japanese approval was based on data from the Phase 2 TRUST clinical program that evaluated taletrectinib in patients globally, including Japan. The MHLW also approved the AmoyDx PLC Panel as a companion diagnostic to identify eligible patients.
"This additional approval by the MHLW further underscores the potential that IBTROZI holds for patients living with advanced ROS1-positive non-small cell lung cancer around the globe," said David Hung, Founder, President, and Chief Executive Officer of Nuvation Bio, according to the press release.
The U.S. Food and Drug Administration granted full approval to IBTROZI on June 11, 2025, for the treatment of locally advanced or metastatic ROS1-positive NSCLC across lines of therapy. China’s National Medical Products Administration approved the drug on January 6, 2025, where it is marketed under the brand name DOVBLERON.
Approximately 2% of NSCLC patients have ROS1-positive disease, with about 35% of newly diagnosed metastatic patients having tumors that have spread to their brain.
Nuvation Bio expects to receive a $25 million milestone payment upon establishment of the reimbursement price in Japan, anticipated in the fourth quarter of 2025. With the company’s next earnings report due on November 5, 2025, investors seeking deeper insights into Nuvation Bio’s financial health and growth prospects can access comprehensive analysis through InvestingPro’s detailed research reports, which cover over 1,400 US stocks including NUVB.
In other recent news, Nuvation Bio Inc. reported its second-quarter earnings for 2025, with results that met analysts’ expectations. The company posted an earnings per share (EPS) of -$0.17, aligning with forecasts. Notably, Nuvation Bio’s revenue significantly exceeded predictions, reaching $4.8 million compared to the anticipated $416,670. This revenue performance marks a substantial beat over the expected figures, highlighting a positive development for the company. The financial results appear to reflect favorably on Nuvation Bio’s ongoing product developments. These recent developments have caught the attention of investors and analysts alike, contributing to a broader understanding of the company’s current financial health.
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