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Investing.com - H.C. Wainwright has reiterated its Buy rating and $45.00 price target on Oruka Therapeutics (NASDAQ:ORKA), a $526 million market cap biotech company, following FDA clearance of the company’s Investigational New Drug application. According to InvestingPro data, the company maintains a strong cash position, holding more cash than debt on its balance sheet.
The FDA clearance allows Oruka to proceed with its Phase 2a trial of ORKA-001, a long-acting anti-IL-23p19 antibody, in moderate-to-severe psoriasis patients. The trial, named EVERLAST-A, will be randomized, double-blind, and placebo-controlled. With analyst targets ranging from $15 to $47, the stock currently trades near $14, though InvestingPro analysis indicates the company is rapidly burning through its cash reserves.
EVERLAST-A will enroll approximately 80 patients randomized 3:1 to receive either ORKA-001 or matching placebo, with PASI 100 at Week 16 as the primary endpoint. At Week 28, patients who achieve PASI 100 will be further randomized to determine if extended dosing intervals are possible.
Additional details on the EVERLAST-A design and interim data from the ORKA-001 Phase 1 study will be presented at the European Academy of Dermatology and Venereology Congress in September, according to the company.
Oruka expects to share efficacy and response duration data from EVERLAST-A in the second half of 2026, with H.C. Wainwright noting that psoriasis trials historically have low placebo rates and good reproducibility across development phases.
In other recent news, Oruka Therapeutics announced that the U.S. Food and Drug Administration 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. This trial will evaluate the safety and efficacy of ORKA-001, enrolling approximately 80 patients to assess complete skin clearance at Week 16. Stifel reiterated its Buy rating on Oruka Therapeutics with a $47 price target, following the IND clearance, and noted that the Phase 2a trial sites are already open and enrolling patients. H.C. Wainwright also maintained a Buy rating for Oruka, setting a $45 price target, as the company commenced dosing in a Phase 1 clinical trial for another drug candidate, ORKA-002. This trial, targeting inflammatory diseases, began dosing ahead of schedule. Additionally, Oruka Therapeutics promoted Laura Sandler to Chief Operating Officer, highlighting her extensive biopharmaceutical leadership experience. These developments reflect significant progress in Oruka’s clinical programs and leadership structure.
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