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Investing.com - Stifel maintained its Buy rating and $47.00 price target on Oruka Therapeutics (NASDAQ:ORKA), representing over 220% upside from the current price of $14.54, following the company’s announcement of IND clearance for ORKA-001. According to InvestingPro data, analysts maintain a strong buy consensus with price targets ranging from $15 to $47.
The IND clearance, based on interim Phase 1 safety and tolerability data, allows Oruka to begin its Phase 2a trial in psoriasis, with data expected in the second half of 2026. Phase 2a trial sites are already open and actively enrolling patients. InvestingPro analysis shows the company maintains a strong financial position with more cash than debt and a healthy current ratio of 30.03, though it’s currently burning through cash rapidly as it advances its clinical programs.
ORKA-001 is a next-generation IL-23p19 inhibitor designed to provide greater exposure and improved dosing compared to Skyrizi. Previous exploratory investigator-sponsored trial results in psoriasis showed superior efficacy and potential for remission in patients who received four times the normal psoriasis dose.
Oruka plans to present complete Phase 1 results for ORKA-001 at the European Academy of Dermatology and Venereology (EADV) conference in September.
The company is also on track to release Phase 1 data for ORKA-002, a next-generation IL-17A/F monoclonal antibody, by the end of 2025, though Stifel notes there is currently limited investor focus on Oruka as a player in the IL-17A/F space.
In other recent news, Oruka Therapeutics announced that the FDA has cleared its investigational new drug application for ORKA-001, allowing the company to proceed with its Phase 2a EVERLAST-A trial in moderate-to-severe psoriasis. The trial will assess the safety and efficacy of ORKA-001, with interim data expected in the second half of 2026. Additionally, Oruka has promoted Laura Sandler to Chief Operating Officer, highlighting her extensive experience in advancing clinical programs. H.C. Wainwright has reaffirmed its Buy rating and a $45 price target for Oruka, citing the company’s efficient progress in its clinical trials. Meanwhile, BTIG has initiated coverage with a Buy rating and a $44 price target, noting the potential of Oruka’s product pipeline. Oruka has also commenced a Phase 1 trial for ORKA-002, a monoclonal antibody targeting IL-17A and IL-17F, with interim data anticipated by the end of 2025. The company plans to advance ORKA-002 into a Phase 2 trial in the first half of 2026, focusing on moderate-to-severe psoriasis. These developments reflect Oruka’s ongoing efforts to advance its therapeutic candidates through clinical stages.
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