Oruka Therapeutics Inc Stock Price, News & Analysis

Oruka Therapeutics (NASDAQ:ORKA) announced positive interim Phase 1 results for ORKA-001, their novel long-acting IL-23p19 antibody for plaque psoriasis treatment. The drug demonstrated an exceptional 100-day half-life, over three times longer than risankizumab, potentially enabling once-yearly dosing.

Key findings include complete STAT3 signaling inhibition through 24 weeks and a favorable safety profile with no severe adverse events. The ongoing EVERLAST-A Phase 2a trial is enrolling approximately 80 patients, with initial data expected in 2H 2026. Additionally, Oruka plans to initiate EVERLAST-B, a dose-ranging Phase 2b trial, in 1H 2026.

Oruka Therapeutics (NASDAQ: ORKA), a clinical-stage biotech company, has reported significant progress in its Q2 2025 pipeline development for chronic skin disease treatments. The company has initiated the EVERLAST-A Phase 2a trial for ORKA-001, their novel IL-23p19 antibody, with first patients dosed and data expected in 2H 2026.

Key financial metrics show a strong position with $351.5 million in cash and equivalents. R&D expenses increased to $24.1 million from $18.7 million year-over-year, while net loss widened to $24.6 million. The company is advancing multiple programs, including ORKA-002 (IL-17A/F antibody) in Phase 1 trials, with data expected around YE 2025, and the development of ORKA-021, a sequential combination therapy.

Oruka Therapeutics (NASDAQ:ORKA) announced FDA clearance of its IND application for the EVERLAST-A Phase 2a trial of ORKA-001, its long-acting anti-IL-23p19 antibody for moderate-to-severe psoriasis. The trial will enroll 80 patients in a 3:1 randomization to receive ORKA-001 or placebo.

The study's primary endpoint is PASI 100 at Week 16. At Week 28, patients achieving complete skin clearance will be randomized 2:1 to either discontinue treatment until disease recurrence or receive doses every six months. The innovative trial design aims to demonstrate potential for yearly dosing and extended treatment-free periods.

Interim Phase 1 data and detailed study design will be presented at the EADV Congress in September, with EVERLAST-A efficacy data expected in 2H 2026.

Oruka Therapeutics (Nasdaq: ORKA), a clinical-stage biotech company focused on developing novel biologics for chronic skin diseases, has announced the promotion of Laura Sandler to the position of Chief Operating Officer. Sandler, who joined Oruka in 2024 as SVP of Operations, brings over 20 years of biopharmaceutical leadership experience.

Prior to joining Oruka, Sandler served as SVP of Development Operations at CRISPR Therapeutics, where she played a key role in the development of exa-cel, the first approved CRISPR-based medicine. Her career includes senior positions at MedImmune, Quintiles, Novartis, and bluebird bio.

Oruka Therapeutics (Nasdaq: ORKA), a clinical-stage biotech company focused on developing novel biologics for chronic skin diseases including plaque psoriasis, has announced its participation in the upcoming Jefferies Global Health Care Conference. The presentation is scheduled for Wednesday, June 4th, 2025, at 12:50 PM ET in New York. Investors and interested parties can access the presentation webcast and replay through Oruka's investor events website at ir.orukatx.com.

Oruka Therapeutics (NASDAQ: ORKA) has begun dosing healthy volunteers in its Phase 1 trial of ORKA-002, a novel half-life extended monoclonal antibody targeting IL-17A/F for treating chronic skin diseases. The trial will evaluate safety, tolerability, and pharmacokinetics across three subcutaneous dose cohorts with approximately 24 participants.

The company expects to share interim data around year-end 2025 and plans to initiate a Phase 2 study in moderate-to-severe psoriasis in 1H 2026. Preclinical data suggests ORKA-002 could enable dosing two to three times per year for psoriasis patients, marking a significant improvement over current standard of care. The planned Phase 2 study will assess multiple dose levels with a primary endpoint of PASI 100 at week 16.

Oruka Therapeutics (NASDAQ: ORKA) reported its Q1 2025 financial results and provided updates on its pipeline programs. The company ended Q1 with a strong cash position of $373 million, providing runway through 2027. Key highlights include:

Their lead program ORKA-001, an IL-23p19 antibody, completed Phase 1 dosing with data expected in Q3 2025. Phase 2a initiation is planned for 2H 2025, with efficacy readout in 2H 2026. The company's second program, ORKA-002, targeting IL-17A/F, has accelerated its Phase 1 initiation to Q2 2025.

Financial results showed R&D expenses of $19.9 million and G&A expenses of $5.2 million for Q1 2025. The company reported a net loss of $21.0 million, which includes $4.9 million in non-cash stock-based compensation.

Oruka Therapeutics (Nasdaq: ORKA), a clinical stage biotech company focused on developing novel biologics for chronic skin diseases including plaque psoriasis, will present at the Bank of America Securities 2025 Health Care Conference.

The presentation is scheduled for Tuesday, May 13th, 2025, at 3:55 PM PT. The company, based in Menlo Park, California, is working to establish new treatment standards in dermatology.

Oruka Therapeutics (ORKA) has revealed promising preclinical data for ORKA-002, their novel extended half-life monoclonal antibody targeting IL-17A/F, at the 2025 AAD Annual Meeting. The drug demonstrated a remarkable half-life of over 30 days in non-human primates - more than triple that of bimekizumab.

Key findings show that ORKA-002 could potentially enable dosing intervals of once every four months to twice yearly in humans, based on projected pharmacokinetics. The drug exhibits equivalent potency and similar binding affinity to bimekizumab, binding IL-17A and IL-17F with comparable picomolar affinity.

The company plans to dose the first subject with ORKA-002 in Q3 2025. The drug is being developed for treating chronic skin diseases, including plaque psoriasis and psoriatic arthritis.