TuHURA Biosciences获FDA孤儿药认定 IFX-2.0有望治疗IIb至IV期皮肤黑色素瘤

美股速递02-02 20:45

TuHURA Biosciences, Inc. (以下简称TuHURA) 宣布，其研发的候选药物IFX-2.0已获得美国食品药品监督管理局（FDA）授予的孤儿药资格认定，适应症为IIb期至IV期皮肤黑色素瘤。

孤儿药认定旨在鼓励针对罕见病的新药研发。获得该认定意味着IFX-2.0在针对这一特定阶段的黑色素瘤治疗方面，有望在药物开发及后续商业化进程中享受一系列政策支持，包括临床试验费用税收抵免、FDA用户费减免以及药物获批后七年的市场独占权。

此次认定标志着IFX-2.0在治疗晚期皮肤黑色素瘤的研发道路上迈出了重要一步。

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