TuHURA Biosciences Files INDA for TBS-2025 with FDA
Written by Emily J. Thompson, Senior Investment Analyst
Updated: 3 days ago
0mins
Should l Buy HURA?
TuHURA Biosciences has filed an Investigational New Drug Application, or INDA, with the FDA's Division of Hematologic Malignancies 1 for the study of TBS-2025, a novel VISTA inhibiting antibody, for the treatment of mutNPM1 relapsed/refractory Acute Myeloid Leukemi, or AML, in combination with a menin inhibitor. TBS-2025 is a unique VISTA-inhibiting monoclonal antibody acquired by the company in its acquisition by merger with Kineta on June 30, 2025. The company plans on initiating a Phase 2 study in menin inhibitor naive patients with mutNPM1 r/r AML utilizing a Simon 2 stage design. Pending completion of FDA review and clearance, the company currently targets initiating the Phase 2 study in early Q2 with preliminary Stage 1 results in Q3.
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Analyst Views on HURA
Wall Street analysts forecast HURA stock price to rise
2 Analyst Rating
2 Buy
0 Hold
0 Sell
Moderate Buy
Current: 1.110
Low
8.00
Averages
9.00
High
10.00
Current: 1.110
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 Files IND for TBS-2025 in AML Treatment
- New Drug Application: TuHURA Biosciences has filed an Investigational New Drug (IND) application with the FDA for TBS-2025, aimed at treating mutNPM1 relapsed/refractory Acute Myeloid Leukemia (AML) in combination with a menin inhibitor, potentially improving patient response rates.
- Clinical Trial Design: The company plans to initiate a Phase 2 clinical trial in menin inhibitor-naïve patients in early Q2 2026, utilizing a Simon 2 stage design, with preliminary results expected in Q3 2026, demonstrating ongoing commitment to this therapeutic area.
- Scientific Rationale: Research indicates that mutations like mutNPM1 may drive VISTA expression on leukemic cells, leading to poor treatment responses; TuHURA believes that adding TBS-2025 could significantly enhance both the CR/CRh rates and their duration, addressing unmet medical needs.
- Safety Assessment: TBS-2025 has shown a favorable safety profile in early trials at a maximum dose of 1,000mg every two weeks, with the optimal Phase 2 dose projected at 750mg every three weeks, laying a solid foundation for further clinical development.
See More
TuHURA Biosciences to Present at Oppenheimer Healthcare Conference
- Presentation Schedule: TuHURA Biosciences' CEO James Bianco will present at the Oppenheimer 36th Annual Healthcare Life Sciences Conference on February 26, 2026, at 3:20 PM ET, showcasing the company's advancements in cancer immunotherapy.
- Clinical Trial Progress: TuHURA is conducting a Phase 3 registration trial for IFx-2.0 as an adjunct therapy to Keytruda®, aimed at overcoming primary resistance to checkpoint inhibitors, which is expected to significantly enhance treatment outcomes for patients with advanced or metastatic Merkel Cell Carcinoma.
- Technological Innovation: The company is also developing first-in-class bi-specific antibody drug conjugates targeting Myeloid Derived Suppressor Cells to inhibit their immune-suppressing effects on the tumor microenvironment, thereby preventing T cell exhaustion and acquired resistance to checkpoint inhibitors, highlighting its cutting-edge position in immuno-oncology.
- Acquisition and Development: TuHURA acquired TBS-2025, a VISTA inhibiting mAb, through its merger with Kineta Inc. on June 30, 2025, which has now entered Phase 2 development, further strengthening the company's product pipeline and market competitiveness.
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 Files IND for TBS-2025 in AML Treatment
- New Drug Application: TuHURA Biosciences has filed an Investigational New Drug (IND) application with the FDA for TBS-2025, aimed at treating mutNPM1 relapsed/refractory Acute Myeloid Leukemia (AML) in combination with a menin inhibitor, potentially improving patient response rates.
- Clinical Trial Design: The company plans to initiate a Phase 2 clinical trial in menin inhibitor-naïve patients in early Q2 2026, utilizing a Simon 2 stage design, with preliminary results expected in Q3 2026, demonstrating ongoing commitment to this therapeutic area.
- Scientific Rationale: Research indicates that mutations like mutNPM1 may drive VISTA expression on leukemic cells, leading to poor treatment responses; TuHURA believes that adding TBS-2025 could significantly enhance both the CR/CRh rates and their duration, addressing unmet medical needs.
- Safety Assessment: TBS-2025 has shown a favorable safety profile in early trials at a maximum dose of 1,000mg every two weeks, with the optimal Phase 2 dose projected at 750mg every three weeks, laying a solid foundation for further clinical development.
See More
TuHURA Biosciences to Present at Oppenheimer Healthcare Conference
- Presentation Schedule: TuHURA Biosciences' CEO James Bianco will present at the Oppenheimer 36th Annual Healthcare Life Sciences Conference on February 26, 2026, at 3:20 PM ET, showcasing the company's advancements in cancer immunotherapy.
- Clinical Trial Progress: TuHURA is conducting a Phase 3 registration trial for IFx-2.0 as an adjunct therapy to Keytruda®, aimed at overcoming primary resistance to checkpoint inhibitors, which is expected to significantly enhance treatment outcomes for patients with advanced or metastatic Merkel Cell Carcinoma.
- Technological Innovation: The company is also developing first-in-class bi-specific antibody drug conjugates targeting Myeloid Derived Suppressor Cells to inhibit their immune-suppressing effects on the tumor microenvironment, thereby preventing T cell exhaustion and acquired resistance to checkpoint inhibitors, highlighting its cutting-edge position in immuno-oncology.
- Acquisition and Development: TuHURA acquired TBS-2025, a VISTA inhibiting mAb, through its merger with Kineta Inc. on June 30, 2025, which has now entered Phase 2 development, further strengthening the company's product pipeline and market competitiveness.
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
