TuHURA Biosciences shares surge 32.50% intraday after FDA grants Orphan Drug Designation for IFx-2.0 in cutaneous melanoma treatment.

TuHURA Biosciences (NASDAQ:HURA) surged 32.50% intraday after the U.S. Food and Drug Administration granted Orphan Drug Designation (ODD) to its lead candidate, IFx-2.0, for treating advanced cutaneous melanoma. The ODD, based on positive Phase 1 trial data showing safety and clinical benefit in patients previously unresponsive to checkpoint inhibitors, provides seven years of market exclusivity, tax incentives, and regulatory support. The news reinforced the drug’s potential as a novel therapy in a high-need oncology niche, aligning with the company’s ongoing Phase 3 trial of IFx-2.0 combined with Keytruda for Merkel Cell Carcinoma. The designation underscores investor optimism about regulatory and commercial pathways for the pipeline, driving the sharp intraday rally.