FDA clears Oruka’s IND for psoriasis drug ORKA-001 phase 2a trial

MENLO PARK, Calif. - Oruka Therapeutics, Inc. (NASDAQ:ORKA), a clinical-stage biotech company with a market capitalization of $544 million, announced Monday 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. According to InvestingPro data, the company maintains a strong liquidity position with a current ratio of 30, though it’s currently experiencing rapid cash burn as it advances its clinical programs.

The EVERLAST-A study will evaluate the safety and efficacy of ORKA-001, the company’s long-acting anti-IL-23p19 antibody. The randomized, double-blind, placebo-controlled trial will enroll approximately 80 patients, with participants randomized 3:1 to receive either ORKA-001 or placebo. The primary endpoint is PASI 100 (complete skin clearance) at Week 16. Analysts following the company maintain price targets ranging from $15 to $47, reflecting diverse views on the trial’s potential success. InvestingPro subscribers can access 8 additional key insights about Oruka’s financial health and market position.

"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, in the press release. With the company’s next earnings report due on August 13, 2025, investors are closely monitoring its development progress and cash utilization.

The trial design includes a secondary phase 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 off-treatment remissions.

ORKA-001 is a subcutaneously administered monoclonal antibody targeting IL-23p19. According to the company, preclinical data indicates the drug has a half-life over three times longer than risankizumab, a currently marketed IL-23 inhibitor.

Bruce Strober, the lead Principal Investigator for the EVERLAST-A study, noted, "I’m excited about EVERLAST-A and the potential that ORKA-001 could enable long dosing intervals and greater efficacy than current IL-23 inhibiting medications."

Oruka plans to present interim data from its Phase 1 study and additional details on the EVERLAST-A trial design at the European Academy of Dermatology and Venereology Congress in September. The company expects to share efficacy and response duration data from EVERLAST-A in the second half of 2026.

In other recent news, Oruka Therapeutics has made several significant announcements. The company has commenced a Phase 1 clinical trial for its monoclonal antibody, ORKA-002, aimed at treating inflammatory diseases such as psoriasis by targeting IL-17A and IL-17F. This trial, involving healthy volunteers, started ahead of schedule and is designed to assess safety, tolerability, and pharmacokinetics. Oruka plans to release interim results by the end of 2025, which is earlier than initially anticipated. Analysts from H.C. Wainwright have maintained a Buy rating with a $45 price target, reflecting confidence in the company’s clinical advancements. BTIG also initiated coverage with a Buy rating, setting a $44 price target and expressing optimism about Oruka’s product pipeline. Additionally, Oruka has promoted Laura Sandler to Chief Operating Officer, highlighting her extensive experience in advancing clinical programs. These developments indicate a proactive approach in Oruka’s clinical and operational strategies.

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