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On Tuesday, H.C. Wainwright reaffirmed its Buy rating and a $45.00 price target for Oruka Therapeutics (NASDAQ:ORKA), representing significant upside from the current trading price of $10.95. The biopharmaceutical company recently commenced dosing in a Phase 1 clinical trial for its drug candidate ORKA-002, which is a monoclonal antibody aimed at treating inflammatory diseases by targeting IL-17A and IL-17F. According to InvestingPro data, the stock maintains a strong analyst consensus recommendation, with price targets ranging from $15 to $47.
The initiation of the trial, which involves dosing healthy volunteers, occurred ahead of the previously anticipated schedule, with the first dosing originally expected to begin in the third quarter of 2025. The study is designed to be double-blind and placebo-controlled, focusing on a single ascending dose to assess the drug’s safety, tolerability, and pharmacokinetics across three different dose levels in a total of 24 participants. While the company holds more cash than debt on its balance sheet, InvestingPro analysis indicates rapid cash utilization, a critical factor for investors monitoring clinical-stage biotech companies.
Oruka Therapeutics has expressed its intention to release interim results, including pharmacokinetic data, by the end of 2025. This timeline is also earlier than initially planned, demonstrating the company’s efficient progress in its clinical development program.
Looking forward, Oruka plans to advance ORKA-002 into a Phase 2 trial for the treatment of moderate-to-severe psoriasis in the first half of 2026. This upcoming study will evaluate the safety and efficacy of various dosages and regimens, with the primary measure being the achievement of PASI 100—a complete clearance of psoriasis—at week 16.
The analyst’s reiterated Buy rating and price target reflect confidence in Oruka’s clinical advancements and the potential of its lead drug candidate. The early start of the trial and the expedited timeline for upcoming results may contribute positively to the company’s prospects as it progresses through the clinical stages.
In other recent news, Oruka Therapeutics has initiated a clinical trial for its new drug, ORKA-002, aimed at treating psoriasis. This Phase 1 trial will evaluate the safety, tolerability, and pharmacokinetics of ORKA-002, with interim data expected by the end of 2025. The drug, a monoclonal antibody targeting IL-17A and IL-17F, is designed for less frequent dosing, potentially positioning it as a leading therapy for psoriasis. Additionally, Stifel has maintained its Buy rating on Oruka Therapeutics, with a price target of $49, following the company’s fourth-quarter update for 2024. The firm highlighted the strategic positioning of Oruka in the psoriasis market, particularly with its ORKA-001 product, which is expected to offer best-in-class efficacy and dosing. Meanwhile, BTIG has initiated coverage on Oruka with a Buy rating and a $44 price target, citing optimism for the company’s product pipeline. Oruka’s financial position appears robust, with approximately $394 million in cash and equivalents, providing a financial runway through 2027. These developments reflect Oruka’s ongoing efforts to advance its therapies in the inflammation and immunology sector.
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