Designation offers pathway to expedite regulatory review, pending positive data, and reinforces safusidenib's potential to address significant medical needs for patients with IDH1-mutant glioma

Pivotal Phase 3 SIGMA study enrollment underway

NEW YORK, Aug. 20, 2026 /PRNewswire/ -- Nuvation Bio Inc. (NYSE:NUVB), a global oncology company focused on tackling some of the toughest challenges in cancer treatment, today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation for safusidenib, the company's investigational, oral, brain-penetrant selective inhibitor of mutant IDH1.