Oruka’s ORKA-001 Extension Study Builds Long-Term Case in Psoriasis Market

Oruka Therapeutics, Inc. (ORKA) announced an update on their ongoing clinical study.

Oruka Therapeutics, Inc. is running an extension study called “An Open-label Extension Study to Evaluate the Long-term Safety, Tolerability, and Efficacy of ORKA-001 in Participants With Moderate-to-Severe Plaque Psoriasis.” The goal is to track long-term safety and benefit in patients who already completed a prior Oruka psoriasis trial.

The study tests ORKA-001, an injected drug given under the skin. It is designed to manage moderate-to-severe plaque psoriasis over the long term and may aim for less frequent dosing than many current treatments.

The trial is an interventional Phase 2 study that assigns participants to different dosing schedules without random draw. It is open-label, so both doctors and patients know which option they receive, and the main purpose is treatment rather than prevention or diagnosis.

Participants receive ORKA-001 either once a year or twice a year, while some stay off drug until their skin scores worsen to a set point. This design helps test how durable the drug’s benefit is and whether once-yearly dosing can be enough for some patients.

The study was first submitted on February 26, 2026, indicating the formal launch of this extension phase. The most recent update was filed on March 4, 2026, showing that trial details and status are being actively maintained.

The trial is currently listed as recruiting, which means enrollment and dosing are underway but headline data are still in the future. Primary and final completion dates are not yet posted, so investors should view this as an early but important step in building a long-term dataset.

For investors, the update reinforces Oruka’s push to position ORKA-001 as a potentially infrequent-dose option in a crowded psoriasis market. If long-term safety and once-yearly dosing look solid, it could support a premium profile versus existing biologics and newer agents.

In the near term, the news mainly lifts sentiment by showing pipeline continuity rather than changing revenue forecasts. Longer term, positive extension data could support higher valuation for Oruka and influence peers focused on chronic autoimmune diseases, depending on how results compare with current standard-of-care therapies.

This ORKA-001 extension study remains active and updated, and investors can find further details on the ClinicalTrials portal.

To learn more about ORKA’s potential, visit the Oruka Therapeutics, Inc. drug pipeline page.