TuHURA Biosciences shares surge 11.04% intraday after FDA grants orphan drug designation for IFx-2.0 in cutaneous melanoma treatment.

TuHURA Biosciences surged 11.04% intraday after the U.S. Food and Drug Administration granted Orphan Drug Designation (ODD) to its lead candidate IFx-2.0 for treating stage IIB to IV cutaneous melanoma. The ODD, based on Phase 1 trial data showing safety and clinical benefit in patients resistant to checkpoint inhibitors, provides seven years of market exclusivity, tax incentives, and regulatory support. The company highlighted the designation as validation of IFx-2.0’s potential to address unmet needs in skin cancer and its role in advancing a Phase 3 trial combining IFx-2.0 with Keytruda for Merkel Cell Carcinoma. The news reinforced investor confidence in TuHURA’s immuno-oncology platform, which aims to overcome resistance to immunotherapy, a critical challenge in cancer treatment.