FDA Grants Orphan Drug Designation to TuHURA Biosciences' IFx-2.0 for Cutaneous Melanoma

Reuters

Feb 02

FDA Grants Orphan Drug Designation to TuHURA Biosciences' IFx-2.0 for Cutaneous Melanoma

TuHURA Biosciences, Inc. announced that the U.S. Food and Drug Administration (FDA) Office of Orphan Products Development has granted Orphan Drug Designation to its candidate IFx-2.0 for the treatment of stage IIB to stage IV cutaneous melanoma. This designation provides TuHURA with benefits including seven years of market exclusivity, increased FDA engagement and assistance, tax credits for certain research, research grants, and a waiver of the New Drug Application user fee. No other beneficiary organizations were mentioned.

Disclaimer: This news brief was created by Public Technologies (PUBT) using generative artificial intelligence. While PUBT strives to provide accurate and timely information, this AI-generated content is for informational purposes only and should not be interpreted as financial, investment, or legal advice. Tuhura Biosciences Inc. published the original content used to generate this news brief via PR Newswire (Ref. ID: LA75913) on February 02, 2026, and is solely responsible for the information contained therein.

Disclaimer: Investing carries risk. This is not financial advice. The above content should not be regarded as an offer, recommendation, or solicitation on acquiring or disposing of any financial products, any associated discussions, comments, or posts by author or other users should not be considered as such either. It is solely for general information purpose only, which does not consider your own investment objectives, financial situations or needs. TTM assumes no responsibility or warranty for the accuracy and completeness of the information, investors should do their own research and may seek professional advice before investing.

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ID: LA75913) on February 02, 2026, and is solely responsible for the information contained therein.</span></i>\n</p>\n</div></body></html>\n\n</article>\n</div>\n</body>\n</html>\n","isBrief":false,"type":0,"news_type":1,"symbol":"BK4139","symbol_name":"生物科技","start_time":0,"source_url":"https://api.refinitiv.com/data/news/v1/stories/urn:newsml:reuters.com:20260202:nNDL3l1ggn:1","article_id":"2608691418","we_media_id":"1032215980","thumbnails":[],"rights":null,"url":"https://stock-news.laohu8.com/highlight/detail?id=2608691418","pubTimestamp":1770036322,"columns":[],"sourceInfo":null,"weMediaInfo":{"media_name":"Reuters","introduction":"Reuters.com brings you the latest news from around the world, covering breaking news in markets, business, politics, entertainment and technology","home_visible":1,"id":"1032215980","head_image":"https://community-static.tradeup.com/news/4567337cbdf294b657b1fa87c5488b48"},"summary":"TuHURA Biosciences, Inc. announced that the U.S. Food and Drug Administration  Office of Orphan Products Development has granted Orphan Drug Designation to its candidate IFx-2.0 for the treatment of stage IIB to stage IV cutaneous melanoma. This designation provides TuHURA with benefits including seven years of market exclusivity, increased FDA engagement and assistance, tax credits for certain research, research grants, and a waiver of the New Drug Application user fee. No other beneficiary organizations were mentioned.Disclaimer: This news brief was created by Public Technologies  using generative artificial intelligence. While PUBT strives to provide accurate and timely information, this AI-generated content is for informational purposes only and should not be interpreted as financial, investment, or legal advice. 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