Oruka Therapeutics Shares Fall 5% After Week 28 ORKA-001 Trial Data

Oruka Therapeutics, Inc. (NASDAQ:ORKA) shares fell 5% on Wednesday morning after the biotechnology company reported Week 28 results from its EVERLAST-A Phase 2a trial of ORKA-001 in moderate-to-severe plaque psoriasis.

The company reported a PASI 100 response rate of 71.4% at Week 28, compared with 63.5% at Week 16. The PASI 90 response rate reached 87.3% at Week 28.

According to Oruka, the responses continued to increase six months after patients received their final dose, with no additional treatment administered after Week 4.

EVERLAST-A Enrolled 84 Patients

EVERLAST-A enrolled 84 patients across 26 sites in the United States and Canada.

Participants were randomised on a 3:1 basis to receive either 600 mg of ORKA-001 at Weeks 0 and 4 or placebo.

ORKA-001 is a half-life-extended IL-23p19 monoclonal antibody being developed by Oruka for the treatment of moderate-to-severe plaque psoriasis.

Patients initially assigned to placebo were switched to ORKA-001 at Week 16. At Week 28, 40.0% of these crossover patients achieved PASI 100, compared with 42.9% of patients in the original active-treatment group at the equivalent point following treatment.

Oruka Reports Safety Results Through Week 28

Oruka said the safety profile through Week 28 was consistent with the IL-23p19 drug class.

Between Weeks 16 and 28, upper respiratory tract infection was the only treatment-emergent adverse event reported in at least 5% of patients, occurring in 8% of those receiving ORKA-001.

Two serious adverse events were reported during the study period, neither of which was considered related to ORKA-001.

Further Trial Data Expected in 2026

Oruka plans to report 52-week data from EVERLAST-A in December 2026.

The company also expects to release data from its EVERLAST-B Phase 2b trial during the fourth quarter of 2026.

Oruka Therapeutics stock price