Oruka Therapeutics Inc (NASDAQ:ORKA) saw its stock rise 6.6% after revealing that the U.S. Food and Drug Administration (FDA) has approved its investigational new drug (IND) application to begin a Phase 2a clinical trial of its psoriasis drug, ORKA-001.
The study, named EVERLAST-A, will test Oruka’s extended-duration anti-IL-23p19 antibody in roughly 80 patients suffering from moderate-to-severe plaque psoriasis. Participants will be randomly assigned in a 3:1 ratio to receive either ORKA-001 or a placebo. The trial’s main goal is to measure the number of patients achieving PASI 100—complete skin clearance—by 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.”
An innovative element of the trial will explore the potential for once-yearly dosing. Patients who achieve complete clearance by Week 28 will be randomly assigned to either stop receiving the drug until symptoms return or to continue treatment every six months. This could open the door to longer remission periods without ongoing medication.
Stifel analyst Alex Thompson maintained his Buy rating and $47.00 price target on the stock, noting:
“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 unveil further insights into the EVERLAST-A study design and Phase 1 interim data at the European Academy of Dermatology and Venereology (EADV) Congress this September. Initial results from the ongoing Phase 2a trial, including data on effectiveness and duration of response, are anticipated in the second half of 2026.