NUVB - Nuvation Bio gets FDA nod to start clinical trial for breast cancer therapy

Nuvation Bio (NYSE:NUVB) is trading ~3.1% higher in the pre-market after the company announced that the FDA cleared its investigational new drug (IND) application for NUV-422 as a potential therapy for advanced breast cancer. FDA has already cleared its previous IND application to test NUV-422, a cyclin-dependent kinase (CDK) 2/4/6 inhibitor, as a treatment for high-grade gliomas, including glioblastoma multiforme (GBM). "FDA clearance of our second IND application for NUV-422 is an important milestone for our lead investigational CDK 2/4/6 inhibitor program as we develop our deep pipeline of innovative new cancer therapeutics," remarked David Hung, CEO of Nuvation Bio (NUVB). The company plans to begin a Phase 1/2 trial for NUV-422 in patients with HR+/HER2- advanced breast cancer targeting those who have received hormonal therapy previously in combination with a CDK 4/6 inhibitor. In March, Nuvation Bio (NUVB) announced that the FDA granted the Orphan Drug Designation for NUV-422 as

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Nuvation Bio gets FDA nod to start clinical trial for breast cancer therapy