NUVB - Nuvation Bio wins FDA's Fast Track designation for lead asset

Nuvation Bio (NYSE:NUVB) announced that the FDA granted its Fast Track designation to the company’s lead drug candidate NUV-422 for the treatment of high-grade gliomas, including glioblastoma multiforme. The Fast Track designation is offered by the regulator to accelerate the development and review of drugs targeted at an unmet medical need in the treatment of serious conditions. It facilitates developers to have frequent communications with the regulator enabling the drugs to reach patients faster. The enrollment is underway in an expanded Phase 1/2 monotherapy study for NUV-422 involving adults with recurrent or refractory high-grade gliomas and solid tumors. Data from the Phase 1 portion of the trial is expected in 2022, CEO David Hung said. A cyclin-dependent kinase (CDK) 2/4/6 inhibitor, NUV-422, was granted the Orphan Drug Designation by the FDA in Q1 2021 as a treatment for malignant gliomas.

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Nuvation Bio wins FDA’s Fast Track designation for lead asset