Nuvation Bio (NUVB) said Monday that the UK Medicines and Healthcare products Regulatory Agency has validated the marketing authorization application for taletrectinib, moving it into formal regulatory review.
The drug targets ROS1-positive non-small cell lung cancer, the company said.
The filing is supported by phase 2 TRUST-I and TRUST-II trial data, the company said.
Taletrectinib is already approved in the US, China, and Japan, it added.
Nuvation Bio stock rose 1.5% in Monday's premarket.
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