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Investing.com -- Oruka Therapeutics Inc (NASDAQ:ORKA) stock rose 6.6% after the company announced that the U.S. Food and Drug Administration (FDA) has cleared its investigational new drug (IND) application for a Phase 2a trial of ORKA-001 in moderate-to-severe psoriasis.
The trial, called EVERLAST-A, will evaluate the company’s long-acting anti-IL-23p19 antibody in approximately 80 patients. Participants will be randomized in a 3:1 ratio to receive either ORKA-001 or a matching placebo, with the primary endpoint being PASI 100 (complete skin clearance) at Week 16.
"We’re thrilled by this rapid progress into Phase 2 development, and very excited to start our first psoriasis study," said Lawrence Klein, CEO of Oruka. "We think that ORKA-001 can redefine the standard of care in this important disease with potential for once per year dosing, off-treatment remissions and higher rates of disease clearance."
The trial design includes a unique feature where patients who achieve complete skin clearance at Week 28 will be randomized to either receive no additional doses until disease recurrence or continue with dosing every six months. This approach aims to evaluate the potential for yearly dosing and extended remission periods without treatment.
Stifel analyst Alex Thompson reiterated a Buy rating and $47.00 price target on Oruka Therapeutics (NASDAQ:ORKA). The analyst commented, "We caught up with management who noted that the IND clearance was based on interim Ph1 data (safety/tolerability) and Ph2a sites are open and actively enrolling--Ph1 results to be presented at EADV in September."
The company plans to present additional details on the EVERLAST-A design and interim data from its Phase 1 study at the European Academy of Dermatology and Venereology Congress in September. Efficacy and response duration data from the Phase 2a trial are expected in the second half of 2026.
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