TuHURA Biosciences, Inc.
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- TuHURA Biosciences, Inc. (NASDAQ:HURA) is a Phase 3 registration-stage immuno-oncology company that develops novel technologies to overcome primary and acquired resistance to cancer immunotherapies such as checkpoint inhibitors and cellular therapies; its proprietary Immune Fx (IFx) platform harnesses innate immune agonists including the lead candidate IFx-2.0, a personalized intratumoral agonist designed to induce tumor immunogenicity for solid tumors like advanced or metastatic Merkel cell carcinoma, IFx-Hu2.0, and IFx-3.0 an mRNA-based agonist for blood-related cancers such as aggressive lymphoma; the company also advances Delta Opioid Receptor (DOR) technology for first-in-class bi-specific immune modulating antibody drug conjugates (ADCs) and antibody-peptide conjugates (APCs) targeting myeloid derived suppressor cells (MDSCs) to inhibit tumor microenvironment immunosuppression; through the June 2025 acquisition of Kineta, Inc., it added TBS-2025 (formerly KVA12123), a Phase 2-ready VISTA-inhibiting monoclonal antibody for NPM1-mutated relapsed/refractory acute myeloid leukemia (AML) in combination with menin inhibitors, with plans to initiate a randomized Phase 2 trial in the second half of 2025 and explore conjugation with DOR inhibitors for enhanced ADCs; in June 2025, it secured a $12.5 million equity financing with tranches tied to milestones including Phase 3 trial initiation for IFx-2.0/Keytruda combination and Kineta merger closure, alongside $3 million in warrant exercises; the company initiated its single randomized placebo-controlled Phase 3 accelerated approval trial of IFx-2.0 as an adjunct to Keytruda in first-line checkpoint-naïve Merkel cell carcinoma patients under FDA Special Protocol Assessment in June 2025. Founded in 1996 as Morphogenesis, Inc. and renamed TuHURA Biosciences, Inc. in December 2023 following a merger with CohBar, Inc., the company is headquartered in Tampa, Florida, and operates primarily in the U.S. with a focus on unmet needs in solid and hematologic malignancies.
Company News
TuHURA Biosciences Receives FDA "Study May Proceed" Notice and IND Clearance for the Evaluation of its TBS-2025 VISTA-Inhibiting Antibody in Molecularly Defined Subsets of AML and Other Blood-Related Cancers
TuHURA Biosciences to Present at the H.C. Wainwright 28th Annual Global Investment Conference
TuHURA Biosciences, Inc. (HURA) Shareholder/Analyst Call Prepared Remarks Transcript
TuHURA Biosciences Highlights Phase III IFx Push, AML Trial Plans at Canaccord
TuHURA Biosciences Reports Second Quarter 2026 Financial Results and Provides a Corporate Update
TuHURA Biosciences to Present at Canaccord Genuity's 46th Annual Growth Conference
TuHURA Biosciences Files Investigational New Drug Application for Evaluation of the TBS-2025 VISTA Inhibiting Antibody in Molecularly Defined Subsets of AML and Other Blood Related Cancers
TuHURA Biosciences Reports First Quarter 2026 Financial Results and Provides a Corporate Update
TuHURA Biosciences to Present at the 4th Annual H.C. Wainwright BioConnect Investor Conference
TuHURA Biosciences Announces $50 Million Credit Facility and Royalty Transaction Extending Anticipated Cash Runway into 2028
TuHURA Biosciences Appoints Amanda Garofalo, MSHS, as Senior Vice President of Clinical Operations
TuHURA Biosciences Reports Fourth Quarter and Full Year 2025 Financial Results and Provides a Corporate Update
Advancements in Novel Immunotherapeutics in The Oncology Battle
Craig Tendler, M.D., JNJ's Former Global Head of Oncology Clinical Development, to Lead TuHURA Bioscience's VISTA Program in AML and other Blood Related Cancers
TuHURA Biosciences (NASDAQ:HURA) Trading Down 3.1% – Here’s Why
TuHURA Biosciences Regains Compliance with Nasdaq Minimum Bid Price Requirement
TuHURA Biosciences Announces Participation in Upcoming Investor Conferences
TuHURA Files Investigational New Drug Application for TBS-2025 in the Treatment of Blood-Related Cancers
TuHURA Biosciences to Present at the Oppenheimer 36th Annual Healthcare Life Sciences Conference
TuHURA Biosciences received FDA Orphan Drug Designation for IFx-2.0 for the Treatment of Stage IIB to Stage IV Cutaneous Melanoma