Nuvation Bio receives FDA Fast Track Designation for glioma drug

Nuvation Bio has received Fast Track Designation from the U.S. Food and Drug Administration (FDA) for safusidenib, an investigational oral drug designed to treat IDH1-mutant glioma. The designation is intended to expedite the development and review process for therapies addressing unmet medical needs.

The decision follows data from the Phase 2 J201 study, which showed a 51.9% confirmed response rate at a median follow-up of 38.8 months. Enrollment is currently underway for the pivotal Phase 3 SIGMA study.

Following the announcement, Cantor Fitzgerald initiated coverage of Nuvation Bio with an ‘Overweight’ rating and a price target of $12, representing a potential 73% upside. Analysts noted the drug's peak sales potential could reach approximately $1.9 billion.