Oruka 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.

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.

Products and 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.

Customers and end 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.

Value-chain role

Oruka operates as a clinical-stage drug developer relying on contract research organizations (CROs), contract manufacturing organizations (CMOs), principal investigators, and third-party suppliers for trial execution and manufacturing. The company does not own manufacturing facilities and has not yet engaged commercial distribution partners.

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.

Source: SEC 10-K, filed 2026-03-12

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