Oruka Therapeutics, Inc.

Oruka Therapeutics, Inc. (Nasdaq: ORKA) is a clinical-stage biopharmaceutical company focused on developing novel monoclonal antibody therapeutics for psoriasis and other inflammatory and immunology indications. The company was formed through the August 2024 acquisition of pre-clinical stage Oruka Therapeutics by ARCA biopharma, Inc., which subsequently changed its name to Oruka Therapeutics, Inc.

Oruka's pipeline centers on two lead programs applying advanced antibody engineering to validated mechanisms of action. ORKA-001 is a high-affinity, extended half-life monoclonal antibody designed to target the p19 subunit of interleukin-23 for psoriasis treatment, engineered with YTE half-life extension technology to support subcutaneous injection as infrequently as once or twice per year. The company initiated Phase 1 trials in the fourth quarter of 2024 and commenced Phase 2a dosing in the third quarter of 2025, with Week 16 data expected in the second quarter of 2026. ORKA-002 targets interleukin-17A and interleukin-17F for treatment of psoriasis, hidradenitis suppurativa, psoriatic arthritis, and other conditions. Phase 1 results announced in January 2026 demonstrated a half-life of approximately 75-80 days, supporting twice-yearly maintenance dosing in psoriasis and quarterly dosing in hidradenitis suppurativa. Phase 2 trials for ORKA-002 in psoriasis commenced in February 2026, with data anticipated in 2027. The company also maintains a third program, ORKA-003, targeting an undisclosed pathway for potential indication expansion.

Oruka's intellectual property derives from license agreements with Paragon Therapeutics, Inc., which granted exclusive worldwide rights to develop and commercialize certain antibodies targeting IL-23 and IL-17A/F outside inflammatory bowel disease. The company's strategy emphasizes applying antibody engineering innovations to validated disease targets, leveraging clinical evidence from existing approved therapies to optimize efficacy, safety, and dosing convenience. Oruka's management team comprises experienced biopharmaceutical professionals from organizations including CRISPR Therapeutics, Celgene, Novartis, CymaBay Therapeutics, and Protagonist Therapeutics. The global psoriasis market represents approximately $28 billion in annual sales as of 2024, with estimated growth to $40 billion by 2032.