TuHURA Biosciences, Inc. (NASDAQ: HURA) announced that the U.S. Food and Drug Administration’s Office of Orphan Products Development has granted Orphan Drug Designation (ODD) to its lead innate‑immune agonist, IFx‑2.0, for the treatment of stage IIB‑IV cutaneous melanoma.
The designation, awarded on February 2 2026, gives the company seven years of market exclusivity, tax credits for qualifying research, and a waiver of the New Drug Application user fee. It also provides FDA engagement and assistance that can accelerate the development pathway for the new indication.
IFx‑2.0 is already in a Phase 3 registration trial in combination with Merck’s Keytruda® for first‑line Merkel cell carcinoma. The orphan status for melanoma expands the potential market for the drug and signals regulatory confidence in the safety and efficacy data from the company’s Phase 1 study, which showed no dose‑limiting toxicities and clinical benefit in patients refractory to checkpoint inhibitors.
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