TuHURA Biosciences Receives Orphan Drug Status for IFx-2.0 in Stage IIB-IV Cutaneous Melanoma

TuHURA Biosciences has received Orphan Drug Designation from the FDA for its investigational therapy IFx-2.0 in treating stage IIB-IV cutaneous melanoma. The designation was based on Phase 1 study results, which showed IFx-2.0 to be safe and well-tolerated. The therapy aims to overcome primary resistance to checkpoint inhibitors. Benefits of the designation include market exclusivity, FDA support, tax credits, research grants, and a user fee waiver.