Oruka Therapeutics Inc
orukatx.comOruka Therapeutics Inc (NASDAQ: ORKA) is a clinical-stage biopharmaceutical company developing long-acting biologic antibody therapies targeting inflammatory and immunological diseases. The company generates no product revenue as of its 10-K filed 2026-03-12, operating entirely on capital financing while advancing two lead candidates through clinical trials. ORKA-001, an IL-23 inhibitor, and ORKA-002, an IL-17 inhibitor, are both being developed for moderate-to-severe plaque psoriasis (PsO), with ORKA-002 also targeting psoriatic arthritis (PsA), hidradenitis suppurativa (HS), axial spondyloarthritis (axSpA), and additional inflammatory and immunological diseases. The company initiated ORCA-SURGE, a Phase 2 trial of ORKA-002 in moderate-to-severe PsO patients, in February 2026, with approximately 160 patients enrolled. Data from ORCA-SURGE is anticipated in 2027. Oruka was incorporated on February 6, 2024.
Products & Services
ORKA-001: an IL-23 inhibitor biologic in clinical development for moderate-to-severe plaque psoriasis, designed for extended dosing intervals. ORKA-002: an IL-17 inhibitor biologic in Phase 2 development (ORCA-SURGE trial initiated February 2026) for moderate-to-severe PsO, PsA, HS, axSpA, and additional inflammatory and immunological diseases. ORCA-SURGE is a Phase 2 randomized trial evaluating 40 mg, 160 mg, and 320 mg doses at Weeks 0 and 4 against placebo, with a primary endpoint of PASI 100 at Week 16 and maintenance dosing evaluating twice-yearly administration.
Revenue Model
Oruka Therapeutics has no product revenue as of the 10-K filed 2026-03-12. The company is pre-commercial and funds operations through equity financing. All expenditures are directed toward clinical development of ORKA-001 and ORKA-002.
Customers & Markets
Target patient populations include adults with moderate-to-severe plaque psoriasis, psoriatic arthritis, hidradenitis suppurativa, and axial spondyloarthritis. Oruka estimates that approximately one-quarter to one-third of moderate-to-severe PsO patients also have PsA, representing a defined subset addressable by ORKA-002. No commercial customers exist as of the filing date.
Geographic Exposure
Oruka is incorporated in the United States and subject to FDA regulatory requirements as its primary approval pathway. The 10-K also discusses EU regulatory frameworks (EMA, GDPR, SmPC requirements), indicating contemplated international development activity, though no non-U.S. operations or trials are specified as active as of the filing date.
Financial Snapshot
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