Nuvation Bio Inc. (NUVB) announced on Monday that the U.S. Food and Drug Administration (FDA) has granted Priority Review status to the company's New Drug Application (NDA) for Taletrectinib. The FDA has assigned a Prescription Drug User Fee Act (PDUFA) target date of June 23 for its decision.
Taletrectinib, an oral investigational and next-generation ROS1 tyrosine kinase inhibitor, is proposed as a treatment for patients diagnosed with advanced ROS1-positive non-small cell lung cancer.
The NDA submission is supported by combined safety and efficacy data derived from the pivotal Phase 2 TRUST-I and TRUST-II clinical trials involving Taletrectinib.
In pre-market trading, Nuvation Bio's shares have risen by 4.43%, currently priced at $2.79 on the New York Stock Exchange.
