Rodman & Renshaw initiated coverage of TuHURA Biosciences (NASDAQ:HURA) with a “buy” rating and price target of $7.00. The stock closed at $3.15 on April 14th.
TuHURA is currently undertaking a Phase 3 trial for its lead asset, IFx-2.0, in an accelerated approval trial with a Special Protocol Assessment (SPA) agreement with the FDA as an adjunctive therapy to pembrolizumab in first-line advanced or metastatic Merkel cell carcinoma (MCC). The primary endpoint of Overall Response Rate (ORR) qualifies for accelerated approval, while the key secondary endpoint of Progression Free Survival (PFS) could satisfy the confirmatory trial requirement, potentially allowing a single study to support both accelerated and full approval without a post-marketing confirmatory study. Enrollment completion is targeted for late 2026 to mid-2027, with topline results expected in 2H27. Phase 1b data in CPI-resistant and CPI-naive MCC patients provide a compelling efficacy foundation for the ongoing registration trial, with durable responses that compare favorably to pembrolizumab monotherapy benchmarks from the KEYNOTE-017 and KEYNOTE-913 studies.
Through the June 2025 acquisition of Kineta, TuHURA added TBS-2025, a VISTA-inhibiting monoclonal antibody targeting mutNPM1 relapsed/refractory acute myeloid leukemia in combination with a menin inhibitor. An IND was filed with the FDA on February 17, 2026, and initiation of a Phase 1b/2 trial comprising an abbreviated Phase 1b dose escalation in mutNPM1 relapsed/refractory AML followed by a Phase 2 combination study with a menin inhibitor is targeted for as early as 2H26, pending FDA clearance. At the discovery level, TuHURA presented data at the 67th ASH Annual Meeting in December 2025 demonstrating that the Delta Opioid Receptor is expressed on tumor-associated MDSCs and tumor-associated macrophages (TAMs) and plays a functional role in their immunosuppressive phenotypes, forming the scientific foundation for the company’s DOR-targeting therapeutic strategy.
At a market capitalization of approximately $182 million, TuHURA trades at a fraction of the potential value embedded across its three technology platforms, contends Rodman & Renshaw’s Director of Research and Senior Biotechnology Analyst, Michael King Jr.
“The 2026 catalyst calendar is unusually dense for a company of this size, including: preliminary IFx-2.0 Phase 1b/2a basket trial data at ESMO in 2H26, initiation of the Phase 1b/2 study of TBS-2025 as early as 2H26 with preliminary Stage 1 data expected in 4Q26, and the planned initiation of preclinical ADC in vivo proof-of-concept studies in 2H26, together representing a multi- inflection-point year that, in our view, the current valuation does not reflect,” writes Mr. King.
“The $7 price target is derived from a probability-adjusted SOTP analysis applying a 4x EV/Sales multiple to risk-adjusted peak revenues for each asset, discounted at a 12% WACC, yielding a risk adjusted enterprise value around $850 million or $7.28 per share,” he adds.
