TuHURA Biosciences Receives FDA Orphan Drug Designation
Written by Emily J. Thompson, Senior Investment Analyst
Updated: 6d ago
0mins
Should l Buy HURA?
Source: Newsfilter
- Orphan Drug Designation: TuHURA Biosciences' IFx-2.0 has received FDA Orphan Drug Designation for treating stage IIB to IV cutaneous melanoma, indicating the potential of new therapies in cancer immunotherapy and addressing the urgent market need for innovative treatment options.
- Clinical Trial Results: The previous Phase 1 study of IFx-2.0 demonstrated safety with no serious dose-limiting toxicities, and patients who were refractory to anti-PD-1 therapy showed clinical benefits upon subsequent treatment, highlighting its promising application in treating resistant melanoma.
- Market Exclusivity Advantage: With the Orphan Drug Designation, IFx-2.0 will enjoy seven years of market exclusivity, and the increased engagement from the FDA is expected to accelerate its development process, potentially leading to significant commercial benefits for the company.
- Future Development Focus: TuHURA is currently focused on the Phase 3 study of IFx-2.0 in combination with Keytruda® for the first-line treatment of advanced or metastatic Merkel Cell Carcinoma, aiming to provide new treatment options and further solidify its position in the oncology immunotherapy space.
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Analyst Views on HURA
Wall Street analysts forecast HURA stock price to rise over the next 12 months. According to Wall Street analysts, the average 1-year price target for HURA is 9.00 USD with a low forecast of 8.00 USD and a high forecast of 10.00 USD. However, analyst price targets are subjective and often lag stock prices, so investors should focus on the objective reasons behind analyst rating changes, which better reflect the company's fundamentals.
2 Analyst Rating
2 Buy
0 Hold
0 Sell
Moderate Buy
Current: 0.440
Low
8.00
Averages
9.00
High
10.00
Current: 0.440
Low
8.00
Averages
9.00
High
10.00
About HURA
TuHURA Biosciences, Inc. is a Phase III registration-stage immuno-oncology company developing novel technologies to overcome resistance to cancer immunotherapy. Its lead innate immune agonist, IFx-2.0, is designed to overcome primary resistance to checkpoint inhibitors. It has initiated a single randomized placebo-controlled Phase III registration trial of IFx-2.0 administered as an adjunctive therapy to Keytruda (pembrolizumab) compared to Keytruda plus placebo in first-line treatment for advanced or metastatic Merkel Cell Carcinoma. It is leveraging its Delta Opioid Receptor technology to develop bi-specific antibody drug conjugates and antibody peptide conjugates targeting Myeloid Derived Suppressor Cells to inhibit their immune-suppressing effects on the tumor microenvironment to prevent T cell exhaustion and acquired resistance to checkpoint inhibitors and cellular therapies. It is also focused on the novel VISTA inhibiting mAb, known as TBS-2025.
About the author
Emily J. Thompson
Emily J. Thompson, a Chartered Financial Analyst (CFA) with 12 years in investment research, graduated with honors from the Wharton School. Specializing in industrial and technology stocks, she provides in-depth analysis for Intellectia’s earnings and market brief reports.
TuHURA Biosciences Receives Orphan Drug Designation for IFx-2.0
- Orphan Drug Designation: TuHURA Biosciences' IFx-2.0 has received Orphan Drug Designation from the FDA, based on early trial data indicating safety and efficacy in some patients, which is expected to provide seven years of market exclusivity and tax incentives, significantly enhancing competitive positioning.
- Clinical Trial Focus: The company is currently focused on completing enrollment in its Phase 3 trial of IFx-2.0 in combination with Keytruda for the treatment of advanced or metastatic Merkel cell carcinoma, with successful progression directly impacting future market performance and revenue potential.
- Financing and Asset Updates: TuHURA recently completed a financing round raising $15.6 million, which is expected to fund key milestones across its development programs including IFx-2.0 and TBS-2025, thereby strengthening the company's financial backing for R&D efforts.
- Market Sentiment Recovery: On Stocktwits, retail sentiment for TuHURA has turned bullish, with a 7,300% surge in message volume within 24 hours, reflecting strong investor interest in the company's future prospects, despite a 90% decline in stock price over the past year.
See More
TuHURA Biosciences Receives FDA Orphan Drug Designation
- Orphan Drug Designation: TuHURA Biosciences' IFx-2.0 has received FDA Orphan Drug Designation for treating stage IIB to IV cutaneous melanoma, indicating the potential of new therapies in cancer immunotherapy and addressing the urgent market need for innovative treatment options.
- Clinical Trial Results: The previous Phase 1 study of IFx-2.0 demonstrated safety with no serious dose-limiting toxicities, and patients who were refractory to anti-PD-1 therapy showed clinical benefits upon subsequent treatment, highlighting its promising application in treating resistant melanoma.
- Market Exclusivity Advantage: With the Orphan Drug Designation, IFx-2.0 will enjoy seven years of market exclusivity, and the increased engagement from the FDA is expected to accelerate its development process, potentially leading to significant commercial benefits for the company.
- Future Development Focus: TuHURA is currently focused on the Phase 3 study of IFx-2.0 in combination with Keytruda® for the first-line treatment of advanced or metastatic Merkel Cell Carcinoma, aiming to provide new treatment options and further solidify its position in the oncology immunotherapy space.
See More
TuHURA Receives FDA Orphan Drug Designation
- Orphan Drug Designation: TuHURA Biosciences' IFx-2.0 has received Orphan Drug Designation from the FDA for treating stage IIB to IV cutaneous melanoma, indicating the drug's potential in addressing rare diseases and likely attracting increased investment and attention.
- Clinical Trial Results: The Phase 1 study of IFx-2.0 demonstrated good safety and showed that patients refractory to PD-1 therapy experienced clinical benefits upon subsequent treatment, underscoring its significance in cancer immunotherapy.
- Market Exclusivity: With the Orphan Drug Designation, IFx-2.0 will enjoy seven years of market exclusivity, and the FDA's support along with tax incentives will expedite its development process, enhancing the company's position in the competitive biopharmaceutical market.
- Strategic Development Focus: TuHURA is currently focused on the Phase 3 clinical trial of IFx-2.0 in combination with Keytruda®, demonstrating the company's proactive approach to addressing the urgent need for new therapies in skin cancer treatment and positioning itself to meet market demands.
See More
TuHURA Biosciences Releases 1.54M Shares to Kintara CVR Holders Following Clinical Trial Success
- Clinical Trial Success: TuHURA Biosciences announced that Kintara's REM-001 clinical trial met its primary endpoint in ten metastatic cutaneous breast cancer patients, demonstrating safety and signs of clinical efficacy after eight weeks of follow-up, marking a significant advancement in cancer immunotherapy.
- Stock Release Milestone: Following the terms of the Contingent Value Rights Agreement dated October 18, 2024, TuHURA will release 1,539,958 shares of common stock to legacy Kintara stockholders, reflecting the company's commitment to its shareholders and enhancing market confidence.
- Rapid Distribution Plan: The shares are expected to be distributed to CVR holders within the next ten business days, and this swift allocation is likely to bolster investor confidence in TuHURA's future growth prospects.
- Strategic Development Focus: TuHURA is developing novel immunotherapies to overcome resistance to cancer treatments, with ongoing clinical trials for products like IFx-2.0 and TBS-2025, further solidifying its position in the biopharmaceutical industry.
See More
TuHURA Biosciences Advances Phase 3 Trial of IFx-2.0 for Merkel Cell Carcinoma
- Phase 3 Clinical Progress: TuHURA's IFx-2.0, as an adjunctive therapy to Keytruda®, has initiated its Phase 3 trial under a Special Protocol Assessment with the FDA, targeting enrollment completion by Q4 2026, marking a significant milestone in treating advanced Merkel cell carcinoma.
- Funding Support: The company recently secured $15.6 million in equity financing, providing a cash runway to achieve multiple key milestones across its three development programs, reflecting market confidence in its innovative treatment solutions.
- Symposium Insights: At the mini KOL symposium on December 5, 2025, experts expressed strong support for the potential of combining TBS-2025 with a menin inhibitor in NPM1 mutated relapsed/refractory AML, highlighting significant unmet medical needs in this area.
- Future Outlook: Management anticipates completing enrollment for IFx-2.0 in 2026 and plans to present preliminary data at scientific conferences, further solidifying the company's leadership position in the field of cancer immunotherapy.
See More
Post-Market Surge: Stoke Therapeutics, Alpha Tau Medical, and Compass Pathways Top Biotech Gainers
Biotech Stock Movements: Biotech stocks experienced significant fluctuations in after-hours trading, with several companies rebounding after losses during regular trading hours, driven by clinical data, FDA designations, and financing news.
Stoke Therapeutics Surge: Stoke Therapeutics saw its stock rise to $33.95 (+11.42%) after presenting positive data on zorevunersen for Dravet syndrome in collaboration with Biogen at a recent conference.
Alpha Tau Medical Gains: Alpha Tau Medical's shares surged by 25.26% to $5.30 after announcing the treatment of its first patient in a pilot study for recurrent glioblastoma multiforme using its Alpha DaRT technology.
FDA Designation for Senti Biosciences: Senti Biosciences' stock increased to $1.60 (+3.92%) following the FDA granting RMAT designation to its investigational CAR-NK cell therapy for acute myeloid leukemia and other hematologic malignancies.
See More
TuHURA Biosciences Receives Orphan Drug Designation for IFx-2.0
- Orphan Drug Designation: TuHURA Biosciences' IFx-2.0 has received Orphan Drug Designation from the FDA, based on early trial data indicating safety and efficacy in some patients, which is expected to provide seven years of market exclusivity and tax incentives, significantly enhancing competitive positioning.
- Clinical Trial Focus: The company is currently focused on completing enrollment in its Phase 3 trial of IFx-2.0 in combination with Keytruda for the treatment of advanced or metastatic Merkel cell carcinoma, with successful progression directly impacting future market performance and revenue potential.
- Financing and Asset Updates: TuHURA recently completed a financing round raising $15.6 million, which is expected to fund key milestones across its development programs including IFx-2.0 and TBS-2025, thereby strengthening the company's financial backing for R&D efforts.
- Market Sentiment Recovery: On Stocktwits, retail sentiment for TuHURA has turned bullish, with a 7,300% surge in message volume within 24 hours, reflecting strong investor interest in the company's future prospects, despite a 90% decline in stock price over the past year.
See More
TuHURA Biosciences Receives FDA Orphan Drug Designation
- Orphan Drug Designation: TuHURA Biosciences' IFx-2.0 has received FDA Orphan Drug Designation for treating stage IIB to IV cutaneous melanoma, indicating the potential of new therapies in cancer immunotherapy and addressing the urgent market need for innovative treatment options.
- Clinical Trial Results: The previous Phase 1 study of IFx-2.0 demonstrated safety with no serious dose-limiting toxicities, and patients who were refractory to anti-PD-1 therapy showed clinical benefits upon subsequent treatment, highlighting its promising application in treating resistant melanoma.
- Market Exclusivity Advantage: With the Orphan Drug Designation, IFx-2.0 will enjoy seven years of market exclusivity, and the increased engagement from the FDA is expected to accelerate its development process, potentially leading to significant commercial benefits for the company.
- Future Development Focus: TuHURA is currently focused on the Phase 3 study of IFx-2.0 in combination with Keytruda® for the first-line treatment of advanced or metastatic Merkel Cell Carcinoma, aiming to provide new treatment options and further solidify its position in the oncology immunotherapy space.
See More
TuHURA Receives FDA Orphan Drug Designation
- Orphan Drug Designation: TuHURA Biosciences' IFx-2.0 has received Orphan Drug Designation from the FDA for treating stage IIB to IV cutaneous melanoma, indicating the drug's potential in addressing rare diseases and likely attracting increased investment and attention.
- Clinical Trial Results: The Phase 1 study of IFx-2.0 demonstrated good safety and showed that patients refractory to PD-1 therapy experienced clinical benefits upon subsequent treatment, underscoring its significance in cancer immunotherapy.
- Market Exclusivity: With the Orphan Drug Designation, IFx-2.0 will enjoy seven years of market exclusivity, and the FDA's support along with tax incentives will expedite its development process, enhancing the company's position in the competitive biopharmaceutical market.
- Strategic Development Focus: TuHURA is currently focused on the Phase 3 clinical trial of IFx-2.0 in combination with Keytruda®, demonstrating the company's proactive approach to addressing the urgent need for new therapies in skin cancer treatment and positioning itself to meet market demands.
See More
TuHURA Biosciences Releases 1.54M Shares to Kintara CVR Holders Following Clinical Trial Success
- Clinical Trial Success: TuHURA Biosciences announced that Kintara's REM-001 clinical trial met its primary endpoint in ten metastatic cutaneous breast cancer patients, demonstrating safety and signs of clinical efficacy after eight weeks of follow-up, marking a significant advancement in cancer immunotherapy.
- Stock Release Milestone: Following the terms of the Contingent Value Rights Agreement dated October 18, 2024, TuHURA will release 1,539,958 shares of common stock to legacy Kintara stockholders, reflecting the company's commitment to its shareholders and enhancing market confidence.
- Rapid Distribution Plan: The shares are expected to be distributed to CVR holders within the next ten business days, and this swift allocation is likely to bolster investor confidence in TuHURA's future growth prospects.
- Strategic Development Focus: TuHURA is developing novel immunotherapies to overcome resistance to cancer treatments, with ongoing clinical trials for products like IFx-2.0 and TBS-2025, further solidifying its position in the biopharmaceutical industry.
See More
TuHURA Biosciences Advances Phase 3 Trial of IFx-2.0 for Merkel Cell Carcinoma
- Phase 3 Clinical Progress: TuHURA's IFx-2.0, as an adjunctive therapy to Keytruda®, has initiated its Phase 3 trial under a Special Protocol Assessment with the FDA, targeting enrollment completion by Q4 2026, marking a significant milestone in treating advanced Merkel cell carcinoma.
- Funding Support: The company recently secured $15.6 million in equity financing, providing a cash runway to achieve multiple key milestones across its three development programs, reflecting market confidence in its innovative treatment solutions.
- Symposium Insights: At the mini KOL symposium on December 5, 2025, experts expressed strong support for the potential of combining TBS-2025 with a menin inhibitor in NPM1 mutated relapsed/refractory AML, highlighting significant unmet medical needs in this area.
- Future Outlook: Management anticipates completing enrollment for IFx-2.0 in 2026 and plans to present preliminary data at scientific conferences, further solidifying the company's leadership position in the field of cancer immunotherapy.
See More
Post-Market Surge: Stoke Therapeutics, Alpha Tau Medical, and Compass Pathways Top Biotech Gainers
Biotech Stock Movements: Biotech stocks experienced significant fluctuations in after-hours trading, with several companies rebounding after losses during regular trading hours, driven by clinical data, FDA designations, and financing news.
Stoke Therapeutics Surge: Stoke Therapeutics saw its stock rise to $33.95 (+11.42%) after presenting positive data on zorevunersen for Dravet syndrome in collaboration with Biogen at a recent conference.
Alpha Tau Medical Gains: Alpha Tau Medical's shares surged by 25.26% to $5.30 after announcing the treatment of its first patient in a pilot study for recurrent glioblastoma multiforme using its Alpha DaRT technology.
FDA Designation for Senti Biosciences: Senti Biosciences' stock increased to $1.60 (+3.92%) following the FDA granting RMAT designation to its investigational CAR-NK cell therapy for acute myeloid leukemia and other hematologic malignancies.
See More
