TuHURA gains FDA orphan drug designation for IFx-2.0 in cutaneous melanoma
May 17, 2026
TuHURA Biosciences said the FDA granted orphan drug designation to IFx-2.0 for stage IIB to stage IV cutaneous melanoma based on Phase 1 data. The company said its Phase 3 IFx-2.0 study in first-line Merkel cell carcinoma continues to enroll.