TuHURA Biosciences received FDA Orphan Drug Designation for IFx-2.0 for the Treatment of Stage IIB to Stage IV Cutaneous Melanoma [Yahoo! Finance]
TuHURA Biosciences, Inc. (HURA)
Company Research
Source: Yahoo! Finance
developing novel therapeutics to overcome resistance to cancer immunotherapy, today announced that the U.S Food and Drug Administration's (FDA) Office of Orphan Products Development has granted Orphan Drug Designation (ODD) to IFx-2.0 for the treatment of stage IIB to stage IV cutaneous melanoma. The ODD designation was based on data from the Company's previously completed Phase 1 study of IFx-2.0, results of which were published in the journal Molecular Therapeutics and entitled: " First-in-Human Stage II/IV Melanoma Clinical Trial of Immune Priming Agent IFx-Hu2.0 ," authored by Dr. Joseph Markowitz, Department of Cutaneous Oncology, H. Lee Moffitt Cancer Center and Research Institute. The study demonstrated IFx-Hu2.0 to be safe with no serious dose limiting toxicities in addition to demonstrating that patients refractory to checkpoint inhibitor therapy (anti-PD1) experienced clinical benefit upon subsequent anti-PD1 based treatment. Dr. James Bianco, President and Chief Executi
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HURA
News
- TuHURA Biosciences (NASDAQ:HURA) had its "buy" rating reaffirmed by analysts at HC Wainwright. They now have a $10.00 price target on the stock.MarketBeat
- TuHURA Biosciences received FDA Orphan Drug Designation for IFx-2.0 for the Treatment of Stage IIB to Stage IV Cutaneous MelanomaPR Newswire
- TuHURA Biosciences (NASDAQ:HURA) had its "sell (e+)" rating reaffirmed by analysts at <a style="font-weight:bold" href="https://weissratings.com/">Weiss Ratings</a>.MarketBeat
- TuHURA Biosciences (NASDAQ:HURA) had its "buy" rating reaffirmed by analysts at HC Wainwright.MarketBeat
- TuHURA Biosciences Announces its Release of Kintara's Contingent Value Right (CVR) as Kintara's REM-001 Meets Primary Safety Endpoint Achieving Contractual Milestone [Yahoo! Finance]Yahoo! Finance
HURA
Earnings
- 11/14/25 - Beat
HURA
Sec Filings
- 1/30/26 - Form 8-K
- 1/8/26 - Form 4
- 1/8/26 - Form 4
- HURA's page on the SEC website