Nuvation Bio wins FDA fast-track status for safusidenib in IDH1-mutant glioma
NUVB•FDA fast-track designation for safusidenib
- Nuvation Bio received FDA Fast Track designation for safusidenib in IDH1-mutant glioma, a step that could speed development and review.
- Updated Phase 2 J201 results were already presented, showing durable patient responses with a favorable long-term safety profile.
- A pivotal Phase 3 SIGMA trial is enrolling, positioning the program for a potential expedited regulatory filing if outcomes hold.
