TuHURA Biosciences Advances Phase 3 Trial of IFx-2.0 for Merkel Cell Carcinoma
Written by Emily J. Thompson, Senior Investment Analyst
Updated: Dec 11 2025
0mins
Source: PRnewswire
- 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.
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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: 0.561
Low
8.00
Averages
9.00
High
10.00
Current: 0.561
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 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.
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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.
Continue Reading