Nuvation Bio Inc. (NUVB), Monday announced that the U.S. Food and Drug Administration has granted Priority Review for the company's New Drug Application for Taletrectinib and assigned a Prescription Drug User Fee Act date on June 23.
The company explained that the oral, investigational next-generation ROS1 tyrosine kinase inhibitor could be used for the treatment of patients with advanced ROS1-positive non-small cell lung cancer.
The NDA is based on the pooled safety and efficacy data from the pivotal Phase 2 TRUST-I and TRUST-II studies of Taletrectinib.
During the pre-market hours, Nuvation's stock is trading at $2.79, up 4.43 percent on the New York Stock Exchange.
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