Oruka Stock Jumps as Its Psoriasis Drug Clears Skin Completely in 61% of Patients

Oruka Therapeutics (Nasdaq: ORKA) surged in double digits on Monday, October 26, 2026, after its experimental psoriasis drug ORKA-001 cleared skin completely in 61% of high-dose patients at Week 16 in the Phase 2b EVERLAST-B trial — compared with 0% on placebo. The stock rose more than 13% intraday, breached its 50-day moving average for the first time in over a month, and was on track for its best day since June, according to Stocktwits coverage of the session.

What Happened

Oruka, a Menlo Park-based clinical-stage biotech, announced the Week 16 EVERLAST-B results before the U.S. market opened on October 26. The randomized, double-blind, placebo-controlled Phase 2b trial ran across 36 sites in the United States, Canada and Europe. It enrolled 187 patients with moderate-to-severe plaque psoriasis, split between a 37.5 mg low dose, a 300 mg mid dose, a 600 mg high dose — the mid and high doses given at Weeks 0 and 4 — and placebo.

The headline numbers rose with the dose. In the high-dose group, 61% of patients achieved PASI 100 — complete clearance of their psoriasis — which was the trial's primary endpoint, and 86% achieved PASI 90, meaning at least a 90% improvement in disease severity. The mid dose produced PASI 100 in 44% of patients and the low dose in 43%, while placebo produced complete clearance in no patients. The difference for the high dose was statistically strong, with a p-value below 0.0001.

Why It Is Blowing Up

Two things make this result stand out. First, complete clearance — not partial improvement — is the hardest bar in psoriasis trials, and a majority of high-dose patients cleared it in just 16 weeks. Second, ORKA-001 is designed to be dosed only once or twice a year. It is a half-life extended antibody targeting IL-23p19, a pathway already validated by approved medicines that generally require far more frequent injections. Lead investigator Joel Gelfand of the University of Pennsylvania said the results suggest ORKA-001 is likely to be the most effective IL-23-targeting biologic to date.

Wall Street reacted quickly. Guggenheim reiterated a Buy rating with a $200 price target and, in coverage highlighted by Stocktwits, estimated the treatment could generate about $7 billion in peak sales if it reaches the market — an analyst estimate, not a company forecast. TipRanks noted the data were highly consistent with the earlier EVERLAST-A trial.

Key Facts

Complete clearance: 61% PASI 100 at Week 16 in the 600 mg group versus 0% on placebo; 86% reached PASI 90 and 86% reached clear or almost-clear skin on the investigator assessment.
Safety: Treatment-emergent adverse events occurred in 39% of high-dose patients versus 43% on placebo. The only events in at least 5% of treated patients were upper respiratory tract infection and headache, and no serious adverse events occurred in the high-dose group. No injection-site reactions were reported in patients who received ORKA-001.
Trial design: 187 patients at 36 sites; the study continues through Week 100 to test durability, including re-randomizing complete responders to once-yearly dosing or placebo.
Balance sheet: Oruka held about $1.1 billion in cash and securities as of June 30, 2026, which management says funds operations through a planned biologics license application for ORKA-001 and development of its second program, ORKA-002, according to TipRanks' summary.
Stock move: Shares climbed more than 13% intraday on October 26, trading roughly in the high-$80s to low-$90s after closing Friday near $80, with market capitalization around $5.3 billion.

What Is Next

Oruka plans to discuss Phase 3 plans with regulators and, pending those talks, start Phase 3 trials of the 600 mg dose in the first half of 2027. Before that, investors get two more readouts: 52-week EVERLAST-A results in December 2026 and 16-week results for ORKA-002 from the ORCA-SURGE Phase 2 trial in the first quarter of 2027. EVERLAST-B itself continues to Week 100, with 52-week results expected in the second half of 2027 — the data that will test whether once- or twice-yearly dosing really holds up.

The takeaway matters: this is a mid-stage trial result, not an approval. Phase 3 still has to reproduce these clearance rates in a larger population, and durability data are still to come. Monday's move shows investors see a credible challenge to the current psoriasis standard of care. This article reports what happened and how markets reacted; it is not financial advice.

Sources

FAQ

Why did Oruka stock jump on October 26, 2026?

Oruka announced positive Week 16 Phase 2b results for ORKA-001 in moderate-to-severe plaque psoriasis, and the shares rose more than 13% intraday as analysts highlighted the clearance rates and the drug's commercial potential.

What does PASI 100 mean?

PASI 100 means a 100% improvement on the Psoriasis Area and Severity Index — in plain terms, completely clear skin. In EVERLAST-B, 61% of high-dose patients reached it at Week 16, versus 0% on placebo.

How often would ORKA-001 be dosed?

ORKA-001 is designed for dosing once or twice a year, thanks to its extended half-life. The ongoing trial is testing once-yearly maintenance dosing in patients who achieve complete clearance.

When could ORKA-001 reach patients?

Not soon — it is still in mid-stage testing. Oruka plans Phase 3 trials starting in the first half of 2027, and approval, if the data hold up, would come only after those larger trials finish.