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Nuvation Bio Granted Orphan Drug Designation for NUV-422 for the Treatment of Patients with Malignant Gliomas

Share this article Share this article NEW YORK, March 11, 2021 /PRNewswire/  Nuvation Bio Inc. (NYSE: NUVB), a biopharmaceutical company tackling some of the greatest unmet needs in oncology by developing differentiated and novel therapeutic candidates, today announced that the U.S. Food and Drug Administration (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.  The FDA s Office of Orphan Drug Products grants Orphan Drug Designation to support drug candidates in development for underserved patient populations or rare disorders that affect fewer than 200,000 people in the United States. 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.

Nuvation Bio Granted Orphan Drug Designation for NUV-422 for the Treatment of Patients with Malignant Gliomas