Welcome to our dedicated page for TuHURA Biosciences news (Ticker: HURA), a resource for investors and traders seeking the latest updates and insights on TuHURA Biosciences stock.
TuHURA Biosciences, Inc. (HURA) is a clinical-stage biopharmaceutical company pioneering novel therapies to overcome resistance in cancer immunotherapy. This page serves as the definitive source for official news and press releases related to the company’s advancements in immuno-oncology.
Investors and researchers will find timely updates on IFx-2.0 clinical trials, regulatory milestones, and strategic partnerships. Our curated news collection covers critical developments including Phase 3 trial progress, innovative approaches to tumor microenvironment modulation, and corporate expansions through mergers and acquisitions.
The repository features verified information on key areas: clinical trial designs under Special Protocol Assessment agreements, updates on innate immune response agonists, and advancements in combination therapies with checkpoint inhibitors. All content is sourced directly from company disclosures to ensure accuracy and compliance.
Bookmark this page for streamlined access to TuHURA’s latest scientific breakthroughs and corporate announcements. Regularly updated to reflect new developments, this resource supports informed decision-making for stakeholders tracking innovations in cancer treatment.
TuHURA Biosciences (NASDAQ:HURA) announced that Kintara's REM-001 clinical trial in ten metastatic cutaneous breast cancer patients met its primary safety endpoint with signs of clinical efficacy after eight weeks of follow-up. Under the Contingent Value Rights Agreement dated October 18, 2024, this milestone triggers the release of an aggregate of 1,539,958 shares of TuHURA common stock to legacy Kintara stockholders. The CVR holders are entitled to receive the shares subject to the CVR terms and applicable withholding. The shares are expected to be distributed to CVR holders within the next ten business days.
TuHURA Biosciences (NASDAQ:HURA) provided a corporate update on December 11, 2025 outlining program milestones, recent financing and scientific data.
Key points: the lead Phase 3 IFx-2.0 trial in combination with Keytruda runs under an FDA SPA with enrollment targeted for completion in Q4 2026; a merger added a Phase 2‑ready VISTA antibody (TBS-2025); preclinical and ASH presentations highlighted the Delta Opioid Receptor target and ADC program; and a recent equity financing raised $15.6 million to fund multiple near-term milestones. Management will host a conference call on Dec 11, 2025.
TuHURA Biosciences (NASDAQ:HURA) presented preclinical data at the ASH meeting on Dec 7–8, 2025 showing the Delta Opioid Receptor (DOR) is expressed on tumor-associated myeloid cells and that DOR inhibition reduced their immunosuppressive activity.
Oral data reported DOR on MDSCs with a DOR antagonist reversing MDSC-mediated T cell suppression. Poster data showed DOR upregulation on tumor-associated macrophages (TAMs) and DOR inhibition reversing TAM-driven T cell suppression. The company described a library of highly selective DOR antagonists and plans a lead ADC combining a DOR inhibitor with a VISTA-blocking antibody.
TuHURA Biosciences (NASDAQ: HURA) reported Q3 2025 results and a corporate update on Nov 14, 2025. The company is enrolling a Phase 3 accelerated approval trial of IFx-2.0 as adjunctive therapy with pembrolizumab in first-line advanced/metastatic Merkel cell carcinoma under an SPA agreement with the FDA. TuHURA announced an oral presentation at ASH 2025 for its Delta Opioid Receptor (DOR) research and appointed Michael Turner, Ph.D. as VP Immunology. The company filed for an up to $50 million ATM facility pending effectiveness of an S-3 filed Nov 3, 2025. Q3 R&D expense was $4.9M vs $2.9M prior-year; nine-month operating cash outflow was $22.1M vs $12.1M prior-year. Total shares outstanding were ~51.2M as of Sept 30, 2025.
TuHURA Biosciences (NASDAQ: HURA) announced that research showing Delta Opioid Receptor (DOR) expression on tumor-associated myeloid cells was selected for an oral presentation at the 67th ASH Annual Meeting (Dec 6–9, 2025).
Key findings include the first demonstration of DOR expression on MDSCs and TAMs, evidence that DOR inhibition reprograms multiple MDSC- and TAM-mediated immunosuppressive mechanisms, and collaborative data from The Moffitt Cancer Center showing DOR+ MDSCs in MDS patients with restoration of stem cell proliferation after DOR inhibition.
TuHURA will present an oral talk on Dec 7, 2025, plus two poster presentations Dec 6–7, 2025, highlighting DOR antagonism as a potential strategy to overcome resistance to cancer immunotherapies.
TuHURA Biosciences (NASDAQ:HURA), a Phase 3 immune-oncology company focused on developing cancer immunotherapy resistance treatments, will participate in the 27th Annual H.C. Wainwright Global Investment Conference in New York City.
The company's President and CEO, Dr. James Bianco, will present on September 8, 2025, at 2:30 PM ET. The presentation will provide a company overview, and management will be available for one-on-one meetings. A replay will be accessible on the company's investor relations website.
TuHURA Biosciences (NASDAQ: HURA) reported significant Q2 2025 developments, highlighted by the completion of Kineta's acquisition and its VISTA inhibiting monoclonal antibody (TBS-2025). The company initiated a Phase 3 accelerated approval trial of IFx-2.0 in combination with Keytruda for Merkel cell carcinoma (MCC) treatment under FDA Special Protocol Assessment.
The company strengthened its financial position through a $12.5 million equity financing and received an additional $3 million from warrant exercises. R&D expenses increased to $4.9 million in Q2 2025, up from $2.8 million in Q2 2024. TuHURA plans to initiate a Phase 2 trial for TBS-2025 in AML treatment in 2H 2025 and expects Phase 3 topline results for IFx-2.0 in 2H 2026.
TuHURA Biosciences (NASDAQ:HURA), a Phase 3 immune-oncology company, has been added to the Russell 3000® and Russell 2000® Indexes as part of the 2025 Russell indexes annual reconstitution, effective June 27th, 2025.
The company is currently conducting a Phase 3 accelerated approval trial of IFx-2.0 in combination with Keytruda® as a first-line treatment for advanced or metastatic Merkel cell carcinoma (MCC). Following its recent acquisition of Kineta, Inc., TuHURA plans to advance a novel anti-VISTA antibody into Phase 2 clinical trials for treating NMPL1-mutated Acute Myeloid Leukemia (AML).
TuHURA Biosciences (NASDAQ:HURA) has successfully completed the acquisition of Kineta, Inc. (OTCPK:KANT), adding a Phase 2 ready VISTA inhibiting monoclonal antibody to its immuno-oncology pipeline. The acquired drug candidate, formerly known as KVA1213, has been renamed to TBS-2025.
The acquisition unlocks the fourth tranche of funds from a previously announced $12.5 million PIPE financing. TuHURA plans to initiate a Phase 2 randomized trial in the second half of 2025, investigating TBS-2025 in combination with a menin inhibitor for NPM1 mutated AML treatment.
The strategic acquisition provides synergies with TuHURA's antibody drug conjugate (ADC) technology. The company is exploring the possibility of conjugating TBS-2025 with Delta Opioid Receptor inhibitors to create a bi-functional, bi-specific ADC targeting myeloid derived suppressor cells in the tumor microenvironment.
TuHURA Biosciences (NASDAQ:HURA) has launched its Phase 3 accelerated approval trial for IFx-2.0, an innate immune agonist designed to overcome resistance to checkpoint inhibitors. The trial will evaluate IFx-2.0 as an adjunctive therapy to Keytruda® in first-line treatment of advanced or metastatic Merkel cell carcinoma (MCC).
The study, conducted under an FDA Special Protocol Assessment (SPA), will enroll 118 participants across 22-25 U.S. sites. Previous Phase 1b results showed a 63% overall response rate with durable responses. The trial's success could lead to accelerated approval based on Overall Response Rate (ORR), with Progression Free Survival (PFS) potentially supporting conversion to regular approval without additional confirmatory trials.
The trial initiation triggers a $2.23 million funding tranche from the company's recent $12.5 million PIPE financing.
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