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. (NASDAQ: HURA) is a Phase 3 immuno-oncology company, and the news flow around HURA reflects its focus on overcoming primary and acquired resistance to cancer immunotherapy. This news page aggregates company-issued press releases and other coverage related to TuHURA’s clinical programs, corporate transactions, and financing activities.
Readers can expect updates on TuHURA’s lead innate immune agonist, IFx-2.0, which is being evaluated in a randomized, placebo-controlled Phase 3 registration trial as an adjunctive therapy to Keytruda (pembrolizumab) in first-line treatment for advanced or metastatic Merkel cell carcinoma. News items also cover early-stage and mid-stage clinical work, such as Phase 1b/2a studies in Merkel cell carcinoma of unknown primary origin and plans for Phase 2 development of TBS-2025, the company’s VISTA inhibiting monoclonal antibody in NPM1-mutated relapsed/refractory acute myeloid leukemia.
In addition to clinical milestones, TuHURA’s news includes scientific presentations at major meetings like the American Society of Hematology (ASH) Annual Meeting, where the company has highlighted data on its Delta Opioid Receptor technology and its potential role in reprogramming myeloid-derived suppressor cells and tumor-associated macrophages. Corporate news items detail transactions such as the acquisition of Kineta, Inc., the reverse merger with Kintara Therapeutics, inclusion in the Russell 3000 and Russell 2000 indexes, private placements, at-the-market offering arrangements, and bridge financing.
For investors, researchers, and healthcare professionals following HURA, this page provides a centralized view of TuHURA’s latest announcements on clinical trial progress, pipeline evolution, scientific data releases, and capital markets developments related to its immuno-oncology strategy.
TuHURA (NASDAQ:HURA) filed an IND with FDA DHM1 on Feb 17, 2026 to study TBS-2025, a VISTA inhibiting antibody, combined with a menin inhibitor for mutNPM1 relapsed/refractory AML.
The company plans a Phase 2 Simon two-stage trial in menin inhibitor naïve patients, targeting initiation in early Q2 2026 and preliminary Stage 1 results in Q3 2026, pending FDA clearance. Management said success could prompt seeking accelerated approval guidance.
TuHURA Biosciences (NASDAQ: HURA) announced that CEO Dr. James Bianco will present at the Oppenheimer 36th Annual Healthcare Life Sciences Conference on February 26, 2026 at 3:20 pm ET. A live and archived webcast will be available via the company's investor relations website.
TuHURA Biosciences (NASDAQ:HURA) announced that the FDA granted Orphan Drug Designation (ODD) to IFx-2.0 for treatment of stage IIB to stage IV cutaneous melanoma on February 2, 2026. The ODD was granted based on the company's prior Phase 1 data showing safety and clinical benefit in anti-PD1 refractory patients.
The designation provides seven years of market exclusivity, increased FDA engagement, certain tax credits, research grants, and an FDA user-fee waiver.
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.