TuHURA Biosciences

HURA

Market cap $103M

Phase 3 accelerated approval trial of IFx-2.0 as adjunctive therapy with Keytruda® (pembrolizumab) as a first-line therapy for advanced and metastatic Merkel cell carcinoma (MCC) is underway, conducted under Special Protocol Assessment (SPA) agreement with the U.S. Food and Drug Administration (FDA) Company's Delta Opioid Receptor (DOR) technology selected for an oral presentation, along with 2 poster presentations at the 67th Annual American Society of Hematology (ASH) Annual Meeting and Exposition, taking place in Orlando, Florida on December 6-9, 2025 TAMPA, Fla. , Nov. 14, 2025 /PRNewswire/ -- TuHURA Biosciences, Inc. (NASDAQ:HURA) ("TuHURA"), a Phase 3 immuno-oncology company developing novel therapeutics to overcome resistance to cancer immunotherapy, today reported financial results for the Company's third quarter ended September 30, 2025, and provided a corporate update.

Oral presentation highlights the first time it's been demonstrated that the DOR is expressed on tumor-associated MDSCs, and that DOR inhibition reprograms multiple mechanisms of MDSC- induced immunosuppression representing a new target in overcoming acquired resistance to cancer immunotherapy The first demonstration that DOR is expressed on Tumor-Associated Macrophages (TAMs), with DOR inhibition modulating their immunosuppressive capabilities Presentation from The Moffitt Cancer Center in collaboration with TuHURA scientists demonstrating the presence of the DOR on MDSCs from patients with myeloid dysplastic syndrome (MDS) and restoration of stem cell proliferation with DOR inhibition TAMPA, Fla. , Nov. 3, 2025 /PRNewswire/ -- TuHURA Biosciences, Inc. (NASDAQ: HURA) ("TuHURA"), a Phase 3 immune-oncology company developing novel technologies to overcome resistance to cancer immunotherapy, today announced that its research on the potential role of the Delta Opioid Receptor in controlling the immunosuppressive capabilities of MDSCs was accepted for an oral presentation at the 67th American Society of Hematology (ASH) Annual Meeting and Exposition taking place in Orlando, FL from December 6-9, 2025.

TAMPA, Fla. , Aug. 20, 2025 /PRNewswire/ -- TuHURA Biosciences, Inc. (NASDAQ:HURA) ("TuHURA"), a Phase 3 immune-oncology company developing novel therapeutics to overcome resistance to cancer immunotherapy, today announced that management will present at the 27th Annual H.C.

Completed the acquisition of Kineta, Inc. and its VISTA inhibiting monoclonal antibody (mAb), now named "TBS-2025;" planning to initiate a Phase 2 trial in relapsed/refractory NPM1-mutated Acute Myeloid Leukemia (AML) in combination with a menin inhibitor in 2H 2025 Initiated a Phase 3 accelerated approval trial of IFx-2.0 as adjunctive therapy with Keytruda® (pembrolizumab) as a first-line therapy for advanced and metastatic Merkel cell carcinoma (MCC), conducted under Special Protocol Assessment (SPA) agreement with the U.S. Food and Drug Administration (FDA) Completed a $12.5 million equity financing transaction, and received an additional $3 million in warrant exercise proceeds TAMPA, Fla. , Aug. 14, 2025 /PRNewswire/ -- TuHURA Biosciences, Inc. (NASDAQ: HURA) ("TuHURA" or the "Company"), a Phase 3 immuno-oncology company developing novel technologies to overcome resistance to cancer immunotherapy, today reported financial results for the Company's second quarter ended June 30, 2025, and provided a corporate update.

TAMPA, Fla. , July 1, 2025 /PRNewswire/ -- TuHURA Biosciences, Inc. (NASDAQ:HURA) ("TuHURA" or the "Company"), a Phase 3 immune-oncology company developing novel technologies to overcome resistance to cancer immunotherapy, today announced that the Company has been added to the Russell 3000® Index, with automatic inclusion in the Russell 2000® Index, as a part of the 2025 Russell indexes annual reconstitution.

Acquisition adds Phase 2 ready novel VISTA inhibiting monoclonal antibody (mAb) to TuHURA's late-stage immuno-oncology pipeline TuHURA planning to initiate a Phase 2 randomized trial involving VISTA inhibiting antibody in 2nd Half 2025 Completion of the acquisition unlocks the fourth tranche of funds from $12.5 million aggregate PIPE financing announced June 3, 2025 TAMPA, Fla. , June 30, 2025 /PRNewswire/ -- TuHURA Biosciences, Inc. (NASDAQ:HURA) ("TuHURA"), a Phase 3 immuno-oncology company developing novel technologies to overcome resistance to cancer immunotherapy, today announced the successful completion of the acquisition of Kineta, Inc. (OTCPK:KANT) ("Kineta"), the maker of the novel VISTA inhibiting mAb formerly known as KVA1213, now renamed as TBS-2025.

Phase 3 trial being conducted under a Special Protocol Assessment (SPA) agreement with U.S. Food and Drug Administration (FDA) Primary endpoint of Overall Response Rate (ORR) qualifies for accelerated approval process Key secondary endpoint of Progression Free Survival (PFS) may satisfy the requirement for a post confirmatory trial, converting accelerated approval to regular approval Initiation of the Phase 3 accelerated approval trial unlocks the third tranche of funds from $12.5 million PIPE financing announced on June 3, 2025 TAMPA, Fla. , June 24, 2025 /PRNewswire/ -- TuHURA Biosciences, Inc. (NASDAQ:HURA) ("TuHURA" or the "Company"), a Phase 3 immune-oncology company developing novel technologies to overcome resistance to cancer immunotherapy, today announced the initiation of its Phase 3 accelerated approval trial of IFx-2.0, TuHURA's lead innate immune agonist, in patients with advanced or metastatic Merkel cell carcinoma (MCC).

TAMPA, Fla. and SEATTLE , June 23, 2025 /PRNewswire/ -- TuHURA Biosciences, Inc. (NASDAQ:HURA) ("TuHURA" or the "Company"), a Phase 3 immune-oncology company developing novel technologies to overcome resistance to cancer immunotherapy, today announced with Kineta, Inc. (OTC Pink:KANT) ("Kineta"), a clinical-stage biotechnology company focused on the development of novel immunotherapies in oncology that address cancer immune resistance, that TuHURA stockholders approved all of the proposals set forth at the Company's Special Meeting of Stockholders held today, June 23, 2025 (the "TuHURA Special Meeting").

NEW YORK , June 9, 2025 /PRNewswire/ -- Halper Sadeh LLC, an investor rights law firm, is investigating the following companies for potential violations of the federal securities laws and/or breaches of fiduciary duties to shareholders relating to: TuHURA Biosciences, Inc. (NASDAQ: HURA)'s  merger with Kineta, Inc. If you are a TuHURA shareholder, click here to learn more about your legal rights and options . Vigil Neuroscience, Inc. (NASDAQ: VIGL)'s  sale to Sanofi.

Company anticipates initiating its Phase 3 accelerated approval trial of IFx-Hu2.0 as adjunctive therapy with Keytruda® (pembrolizumab) as first-line treatment for advanced and metastatic Merkel cell carcinoma (MCC), conducted under Special Protocol Assessment (SPA) Agreement with U.S. Food and Drug Administration (FDA), later in June 2025 Resolution of partial clinical hold unlocks second tranche of funds from $12.5 million PIPE financing announced on June 3, 2025 TAMPA, Fla. , June 9, 2025 /PRNewswire/ -- TuHURA Biosciences, Inc. (NASDAQ:HURA) ("TuHURA" or the "Company"), a Phase 3 immune-oncology company developing novel technologies to overcome resistance to cancer immunotherapy, today announced that the FDA has removed the manufacturing-related partial clinical hold on the Company's Phase 3 accelerated approval trial for IFx-2.0, thereby allowing the trial to proceed as agreed to under the previously announced SPA Agreement with the FDA.