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 Biosciences (NASDAQ:HURA) entered a $50 million credit facility with an affiliate of its largest stockholder to fund clinical programs, including IFx-2.0 through anticipated Phase 3 top-line results and TBS-2025 milestones, extending cash runway into 2028.
The facility allows monthly draws, bears 12% annual interest with monthly interest payments, principal due April 21, 2031, is secured by company assets, and includes a low- to mid-single-digit royalty on future IFx-2.0 commercial sales.
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.