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Does Rusfertide’s FDA Breakthrough Therapy Status Shift the Bull Case for Protagonist Therapeutics (PTGX)?
Protagonist Therapeutics announced that rusfertide, its investigational drug for erythrocytosis in polycythemia vera patients, received Breakthrough Therapy Designation from the FDA, building on previous Orphan Drug and Fast Track designations after positive Phase 3 VERIFY study results.
This milestone, achieved through collaboration with Takeda Pharmaceuticals, highlights rusfertide’s clinical promise and advances the company’s timeline for an anticipated New Drug Application in late...