NUVB - Nuvation Bio's NUV-422 wins FDA 'Orphan Drug' status

Nuvation (NUVB) announces that the U.S. FDA has granted Orphan Drug Designation to NUV-422, a cyclin-dependent kinase ((CDK)) 2/4/6 inhibitor, for the treatment of patients with malignant gliomas.Gliomas, which begin in the glial or supportive tissue, represent 75% of malignant primary brain tumors in adults.Orphan Drug Designation qualifies a candidate for various development incentives, including tax credits for eligible clinical trials, waiver of application fees and market exclusivity for seven years upon FDA approval.Patient enrollment and dosing is ongoing in the Phase 1/2 study of NUV-422 in adult patients with recurrent or refractory high-grade gliomas, including glioblastoma multiforme ((GBM)).The Phase 1 dose escalation part of the study is designed to evaluate safety and tolerability, as well as to determine a recommended Phase 2 dose based on the tolerability profile and pharmacokinetic properties of NUV-422. Data from the Phase 1 portion is expected in 2022.

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Nuvation Bio's NUV-422 wins FDA 'Orphan Drug' status