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Nuvation Bio Says FDA Grants Fast Track Designation For Safusidenib, Investigational, Oral, Brain-Penetrant Selective Inhibitor Of Mutant IDH1

BenzingaAug 20, 2026, 12:05 PMBenzinga Newsdesk

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 gliomaPivotal Phase 3 SIGMA

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benzinga
Observed
Aug 20, 2026, 12:05 PM
Checked
Aug 20, 2026, 12:05 PM
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Captured once, then retained as an archive reference
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