Oruka Therapeutics Inc. (Nasdaq: ORKA) reported deeper clinical responses at Week 28 in its Phase 2a EVERLAST-A trial of ORKA-001, an investigational monoclonal antibody for moderate-to-severe plaque psoriasis.
According to the September 23 announcement, 71.4% of the 63 patients initially assigned to ORKA-001 achieved PASI 100 at Week 28, indicating complete skin clearance. The PASI 90 response rate, representing at least a 90% improvement, reached 87.3%.
Patients in that group received 600 milligrams of ORKA-001 at Weeks 0 and 4, with no subsequent doses before the Week 28 assessment. At Week 16, the company had reported PASI 100 and PASI 90 rates of 63.5% and 83%, respectively.
Chief Medical Officer Joana Goncalves said the results showed “responses continuing to deepen months after the last dose.”
ORKA-001 is a half-life-extended antibody targeting IL-23p19, a signaling protein involved in inflammatory diseases such as psoriasis. Oruka is developing the candidate with the goal of achieving durable disease control using less-frequent dosing than currently available biologic treatments. That potential has not yet been established through a Phase 3 trial or a direct comparison with an approved therapy.
EVERLAST-A enrolled 84 patients across 26 sites in the United States and Canada. Participants were initially randomized three-to-one to ORKA-001 or placebo. Patients assigned to placebo crossed over to ORKA-001 at Weeks 16 and 20, meaning the Week 28 assessment did not include a concurrent untreated control group.
Among 20 crossover patients, 40% achieved PASI 100 twelve weeks after receiving their first dose. At the corresponding point after treatment, 42.9% of the original ORKA-001 group had achieved PASI 100.
Between Weeks 16 and 28, upper respiratory tract infection was the only treatment-emergent adverse event reported in at least 5% of treated patients, occurring in seven of 83 patients. Two serious adverse events—a tibial fracture and prostate cancer in a patient with elevated prostate-specific antigen at baseline—were reported. Investigators did not consider either event related to ORKA-001. No injection-site reactions were reported.
The trial remains relatively small, and longer follow-up will be required to evaluate durability and less-common safety events. Oruka expects to report complete 52-week EVERLAST-A results in December 2026.
The company has also enrolled 187 patients in its dose-ranging Phase 2b EVERLAST-B trial. Week 16 results are expected during the fourth quarter of 2026 and are intended to support a Phase 3 program targeted to begin during the first half of 2027.
Oruka reported $1.1 billion in cash, cash equivalents and marketable securities as of June 30, 2026. Its second-quarter net loss increased to $41.2 million from $24.6 million one year earlier, while research and development expenses rose to $43.3 million.
The cash position followed an April public offering that generated approximately $658.3 million in net proceeds through the sale of 9.66 million shares. Oruka expects its available capital to support operations through a potential Biologics License Application for ORKA-001, although that runway remains a management estimate.
Upcoming Catalysts
- Week 16 results from the Phase 2b EVERLAST-B trial in the fourth quarter of 2026
- Complete 52-week EVERLAST-A data in December 2026
- Potential initiation of an ORKA-001 Phase 3 program during the first half of 2027
- Additional safety and durability findings
- Regulatory guidance concerning the Phase 3 program and dosing strategy
Sources
- Oruka reports Week 28 EVERLAST-A results — September 23, 2026
- EVERLAST-A trial record, NCT07090330 — ClinicalTrials.gov
- EVERLAST-B trial record, NCT07290569 — ClinicalTrials.gov
- Oruka second-quarter 2026 financial results
- Oruka Form 10-Q for the quarter ended June 30, 2026 — SEC
Editorial Disclosure
This article is based entirely on publicly available information, including company announcements, SEC filings and the federal clinical-trial registry. Securities discussed or referenced include Oruka Therapeutics Inc. (Nasdaq: ORKA). Biotech Stocks Daily has not received compensation from Oruka Therapeutics, its management, investor relations representatives or any third party for this specific article. Biotech Stocks Daily may have current or past paid business relationships with other companies, which do not influence the content or conclusions of this article. No staff member or principal of Biotech Stocks Daily holds a position in any security mentioned at the time of publication.
Confirmed sources include Oruka Therapeutics’ September 23, 2026 clinical-results announcement, its August 10, 2026 financial update, its Form 10-Q for the quarter ended June 30, 2026 and the ClinicalTrials.gov records for EVERLAST-A and EVERLAST-B. The reported clinical results, safety assessments and anticipated development timelines originated from the company and have not been independently validated by Biotech Stocks Daily.
ORKA-001 remains investigational and has not received regulatory approval. EVERLAST-A is a relatively small Phase 2a study, and patients originally assigned to placebo crossed over to active treatment at Week 16. Consequently, the Week 28 results do not include a concurrent untreated control group. The study did not compare ORKA-001 directly with an approved psoriasis treatment. Longer and larger trials may produce different efficacy or safety findings.
Financial information reflects Oruka’s position as of June 30, 2026 and subsequently disclosed financing activity. The company has no approved product, continues to record operating losses and expects substantial development expenses. Its April public offering, at-the-market sales and outstanding convertible or exercisable securities have increased or may further increase the number of common shares, resulting in dilution. The projected cash runway through a potential BLA filing is a forward-looking management estimate.
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