Key Highlights

  • Oruka Therapeutics (NASDAQ:ORKA) rose 8.37% to about USD 86.86 in early trading on Monday, October 26, 2026, after its 7:00 a.m. ET release of Week 16 results for ORKA-001 in moderate-to-severe psoriasis.
  • The 600 mg dose reached a PASI 100 rate of 61% against 0% for placebo (p<0.0001) among 187 patients in the Phase 2b EVERLAST-B trial.
  • Adverse events occurred in 39% of the high-dose group against 43% on placebo, with no serious events in that group and no injection-site reactions in ORKA-001 patients.
  • The company plans to start Phase 3 trials in the first half of 2027, pending regulatory discussions, and to report 52-week EVERLAST-A data in December 2026.

Week 16 Results Lift Oruka in Early Trading

Oruka Therapeutics (NASDAQ:ORKA), a clinical-stage biotechnology company, released Week 16 results for ORKA-001 at 7:00 a.m. ET on Monday, October 26, 2026, and the shares rose 8.37% to about USD 86.86 in early trading, with prices described as intraday. EVERLAST-B is a Phase 2b trial that randomised 187 patients 1:1:1:1 across 36 sites in the United States, Canada and Europe. The primary endpoint, PASI 100, means complete clearance of psoriasis skin lesions. It was reached by 61% of patients on 600 mg, 44% on 300 mg and 43% on 37.5 mg, against 0% on placebo. The high-dose result was statistically significant at p<0.0001. An investor webcast followed at 8:00 a.m. ET.

Why the Dose Response and Safety Profile Matter

The trial tested a single low dose and two higher doses given at Weeks 0 and 4, so the climb from 43% to 61% complete clearance shows that more drug produced more skin clearance. Secondary measures were closer together: PASI 90, which means a 90% improvement in skin disease, was 70%, 85% and 86% across the three doses, and IGA 0/1, a physician rating of clear or almost clear skin, was 74%, 85% and 86%. Safety supports a Phase 3 choice of 600 mg: the company reported that the most common events, upper respiratory infection and headache, occurred at rates similar to approved IL-23 inhibitors, a class of psoriasis antibodies. Only 3 serious events occurred across all ORKA-001 arms, none treatment-related.

Risks and What to Watch

The first risk is funding, since the release does not state cash or runway and Phase 3 programmes are costly. The second is durability: patients who reached PASI 100 are re-randomised at Week 28 to 600 mg yearly or placebo, and the trial continues to Week 100, so the case for infrequent dosing is not yet proven. The third is expectations, because an 8.37% rise from a high price leaves little room for a slower Phase 3 start. Investors should watch the Fed decision on Wednesday, October 28, 2026, the 52-week EVERLAST-A results in December 2026, ORKA-002 psoriasis data in the first quarter of 2027 and Phase 3 initiation in the first half of 2027.

Where Things Stand

The answer is that Oruka Therapeutics (NASDAQ:ORKA) rose 8.37% because EVERLAST-B delivered 61% complete skin clearance at 600 mg, a clean safety profile and a defined route to Phase 3. The result is a Phase 2b readout, and it does not guarantee approval or commercial success. The next catalysts are the Fed decision on Wednesday, October 28, 2026, EVERLAST-A 52-week data in December 2026 and ORKA-002 results in the first quarter of 2027. Clinical-stage shares are highly volatile, and this is not investment advice.