TuHURA Biosciences shares rise 23.98% intraday after FDA grants Orphan Drug Designation for IFx-2.0 in advanced cutaneous melanoma treatment.

TuHURA Biosciences surged 23.98% intraday following the U.S. Food and Drug Administration’s (FDA) granting of Orphan Drug Designation (ODD) to its IFx-2.0 therapy for stage IIB to IV cutaneous melanoma. The designation, based on Phase 1 trial data showing safety and clinical benefits in patients previously unresponsive to checkpoint inhibitors, underscores IFx-2.0’s potential as a novel therapeutic approach. The ODD provides seven years of market exclusivity, enhanced FDA collaboration, and tax incentives, which could accelerate development of IFx-2.0 in combination with Keytruda for Merkel Cell Carcinoma. Despite the company’s financial challenges, the regulatory milestone and positive clinical readouts aligned with the stock’s sharp intraday rally.