Nuvation Bio temporarily halts NUV-868 development: Focus on late-stage pipeline

In the course of an internal analysis of efficacy and safety data from the Phase 1 monotherapy and Phase 1b combination studies, Nuvation Bio has decided not to proceed with the Phase 2 study of NUV-868 either as a monotherapy or in combination with Olaparib or Enzalutamide in advanced solid tumors. The company is currently evaluating possible next steps for the NUV-868 program, including further development in combination with approved products for indications where BD2-selective BET inhibitors could improve patient outcomes. David Hung, founder, president, and CEO of Nuvation Bio, stated: “As we focus on our late-stage pipeline and prepare to potentially bring Taletrectinib to the U.S. market in 2025, we have decided, after careful review of the data generated in the Phase 1 monotherapy study and Phase 1b study in combination with Olaparib or Enzalutamide, not to initiate a Phase 2 study of NUV-868 in the previously studied solid tumor indications. We are evaluating new potential indications for NUV-868 and will provide updates on further developments.” Two years ago, Nuvation Bio halted the clinical development of NUV-422 following an internal risk-benefit analysis that considered feedback from the FDA in a partial clinical hold letter for the monotherapy Phase 1/2 study as well as clinical hold letters for the combination Phase 1b/2 studies. As of June 30, 2024, Nuvation Bio had liquid assets, cash equivalents, and marketable securities amounting to $577.2 million.