On Friday, H.C. Wainwright maintained its Buy rating and $45.00 price target for Oruka Therapeutics (NASDAQ: ORKA) stock, following the company's announcement that it has started dosing volunteers in the Phase 1 study of its leading drug candidate, ORKA-001.
With analyst targets ranging from $40 to $49 and a strong "Buy" consensus recommendation of 1.14, the company appears undervalued according to InvestingPro analysis. This development signifies a key achievement for Oruka, as it has successfully transitioned its first product into clinical trials ahead of schedule.
The Phase 1 trial is designed to be a double-blind, placebo-controlled, single ascending dose study that involves 24 healthy volunteers across three different dosing groups. The company, currently valued at $727 million and maintaining a strong financial health score of 2.84 according to InvestingPro, has projected to release interim data from this study in the second half of 2025.
Should the Phase 1 results be favorable, Oruka intends to commence a placebo-controlled proof-of-concept study for ORKA-001 targeting moderate-to-severe psoriasis.
The planned proof-of-concept study will aim to enroll around 80 patients, focusing on demonstrating 16-week PASI100 efficacy and assessing the duration of the drug's response. The study will feature a maintenance arm where some participants will receive ORKA-001 every six months. Additionally, the trial will explore the possibility of extending the dosing interval to as long as every 12 months for some patients.
Oruka anticipates the proof-of-concept study data to be available in the latter half of 2026. H.C. Wainwright has reaffirmed its confidence in Oruka with a reiterated Buy rating and a 12-month price target of $45 per share, based on these recent developments and the potential trajectory of ORKA-001.
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