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On Friday, Stifel analysts reiterated a Buy rating on Oruka Therapeutics (NASDAQ: ORKA), maintaining a $49.00 price target - representing significant upside from the current price of $10.07. The firm’s positive outlook follows Oruka’s fourth-quarter update for the year 2024. According to InvestingPro data, analysts maintain a Strong Buy consensus on the stock, despite recent market challenges. Stifel’s analysis suggests that Oruka Therapeutics is strategically positioned to continue its innovative trajectory in the psoriasis market, potentially leading with its ORKA-001 product. While the stock has experienced a significant 59.7% decline over the past six months and currently trades near its 52-week low of $9.44, ORKA-001, which operates through the same mechanism of action as Skyrizi, an IL-23p19 inhibitor, is anticipated to offer best-in-class efficacy and dosing. InvestingPro subscribers can access additional insights about Oruka’s market position and growth potential.
ORKA-001 is progressing as planned, with initial Phase 1 human data expected in the second half of 2025. This data will provide insights into the pharmacokinetics (PK) of the drug. Following this, Phase 2 data on psoriasis is projected for the second half of 2026, aiming to confirm if increased exposure to the drug can significantly improve efficacy, as indicated by results from the KNOCKOUT study.
In addition, Oruka Therapeutics is advancing ORKA-002, which targets IL-17A/F. This compound could potentially surpass the efficacy profile of Bimzelx, another psoriasis treatment. Preclinical data for ORKA-002 was presented at the American Academy of Dermatology (AAD) meeting, held from March 7 to March 11, 2025, with the initiation of Phase 1 trials anticipated in the third quarter of 2025 and pharmacokinetic data expected in the first half of 2026.
The company is also developing ORKA-021, a sequential regimen combining ’001’ and ’002’, designed to enhance the rate of symptom relief and offer superior maintenance dosing. Financially, Oruka Therapeutics is in a strong position, with approximately $394 million in cash and equivalents, providing the company with a financial runway through 2027. With a current market capitalization of $352.44 million, the company’s cash position nearly equals its market value, though InvestingPro analysis indicates the company is not expected to achieve profitability this year, with a forecasted EPS of -$2.82 for 2025.
In other recent news, Oruka Therapeutics has entered into an exclusive licensing agreement with Paragon Therapeutics to develop and commercialize certain antibodies targeting IL-17A/F and IL-23. This deal could lead to up to $22 million in milestone payments to Paragon, with initial payments tied to the nomination of a development candidate and the first human dosing in a Phase 1 trial. Oruka will also pay Paragon royalties on the sales of these antibody products, with a decrease in royalties if no relevant Paragon patents are active. Additionally, H.C. Wainwright has maintained its Buy rating for Oruka Therapeutics, following the commencement of a Phase 1 study for ORKA-001, Oruka’s lead drug candidate. This Phase 1 trial involves 24 healthy volunteers and marks an early clinical success, as the company has initiated dosing ahead of schedule. Oruka plans to release interim data from this study in the second half of 2025 and aims to conduct a proof-of-concept study targeting moderate-to-severe psoriasis. The analyst firm has set a 12-month price target of $45 per share, reflecting confidence in the potential trajectory of ORKA-001. These developments highlight Oruka’s strategic efforts in advancing its clinical pipeline and expanding its biopharmaceutical portfolio.
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