NUVB - Nuvation Bio rises 4% on IND clearance for prostate cancer treatment

Shares of Nuvation Bio (NUVB +3.7%) are higher this morning after the FDA cleared an IND application for NUV-422 for prostate cancer. In December 2020, the company began a phase 1/2 study of NUV-422 for high grade gliomas, later amending the protocol to include HR+/HER2- advanced breast cancer and metastatic castration resistant prostate cancer (mCRPC). Phase 1 data from that trial is expected in 2H 2022. With the IND, Nuvation will begin a phase 1b/2 trial starting with a dose escalation portion on NUV-422 plus Xtandi (enzalutamide) as well as determine a recommended phase 2 dose. The phase 2 part will be an open-label study to evaluate the efficacy and safety of NUV-422 + enzalutamide in previously treated mCRPC patients. Last week, the FDA cleared an IND for NUV-422 in breast cancer.

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Nuvation Bio rises 4% on IND clearance for prostate cancer treatment