TuHURA Biosciences develops immuno-oncology therapeutics designed to address resistance to cancer immunotherapies. Company news centers on its clinical-stage pipeline, including IFx-2.0, an innate immune agonist being studied as adjunctive therapy with Keytruda in advanced or metastatic Merkel Cell Carcinoma, and TBS-2025, a VISTA-inhibiting monoclonal antibody for mutNPM1 relapsed or refractory acute myeloid leukemia.
Recurring updates also cover the Delta Opioid Receptor technology used in immune-modulating antibody drug conjugates and antibody peptide conjugates targeting Myeloid Derived Suppressor Cells. Other company developments include financial results, clinical operations leadership, investor-conference communications, financing arrangements and Nasdaq listing compliance matters.
TuHURA Biosciences (NASDAQ:HURA) appointed Amanda Garofalo, MSHS, as Senior Vice President of Clinical Operations effective April 7, 2026. Garofalo brings over 20 years of Phase I-IV drug and biologic development experience and will oversee day-to-day clinical operations while working with Craig Tendler, M.D.
Her background includes enabling an oversubscribed $305M Series F at Parabilis, managing a portfolio of 200+ oncology trials at EMD Serono, and directing three IND submissions in 12 months at Arcus Biosciences.
TuHURA Biosciences (NASDAQ:HURA) reported 2025 results and a corporate update, highlighting a Phase 3 SPA-backed IFx-2.0 trial in first-line Merkel Cell Carcinoma, a completed $10.5 million acquisition of Kineta rights to TBS-2025, and planned clinical and preclinical milestones through 2027.
Financials show $3.6 million cash at 12/31/2025, R&D of $20.5M, G&A of $7.6M, net operating outflows of $27.7M, and $21.2M gross raised in 2025 financings.
TuHURA Biosciences (NASDAQ: HURA) announced that Dr. Craig L. Tendler will provide strategic and operational services consistent with a Chief Medical Officer while remaining on the Board, to lead development of the VISTA‑blocking antibody TBS‑2025 in AML and other blood cancers.
Dr. Tendler brings ~30 years of oncology and hematology development experience, multiple regulatory approvals and prior leadership on JNJ's menin inhibitor program; TuHURA reports preliminary FDA feedback on early development plans.
TuHURA Biosciences (NASDAQ:HURA) announced it regained compliance with Nasdaq's $1.00 minimum bid price requirement after the company's common stock closed at $1.00 or greater for 11 consecutive business days from Feb 10, 2026 through Feb 25, 2026, and Nasdaq closed the matter on Feb 26, 2026.
The company said it is progressing enrollment in its Phase 3 accelerated approval trial for IFX-2.0 in front-line Merkel Cell Carcinoma, readying TBS 2025 for a Phase 2 study in relapsed/refractory NPM1 mutated AML, and advancing preclinical proof-of-concept for immune modulating antibody drug conjugates.
TuHURA Biosciences (NASDAQ:HURA) announced executive participation in two investor events in March 2026. Dr. James Bianco, president and CEO, will present a webcast at the Citizens Life Science Conference on March 10, 2026 at 4:00 pm ET.
TuHURA will also be available for 1x1 investor meetings at the Leerink Global Healthcare Conference on March 11, 2026. Registration links and a live/archived webcast are available via TuHURA's investor events page.
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.