Recent Updates — ORKA
Oruka Therapeutics announced Week 16 results from its Phase 2b EVERLAST-B clinical trial of ORKA-001, an investigational IL-23p19 monoclonal antibody, in patients with moderate-to-severe plaque psoriasis. In the high-dose (600 mg) group, 61% of patients achieved PASI 100 at Week 16 compared to 0% for placebo (p<0.0001). Additionally, 86% of high-dose patients achieved PASI 90 and IGA 0/1. The drug demonstrated a favorable safety profile with no serious treatment-emergent adverse events in the high-dose group. Oruka plans to initiate Phase 3 trials for ORKA-001 in the first half of 2027, pending regulatory discussions. The company also reported a cash position of $1.1 billion as of June 30, 2026. Oruka Therapeutics is a clinical-stage biotechnology company developing novel biologics for chronic skin diseases including plaque psoriasis and hidradenitis suppurativa.
Oruka Therapeutics reported second quarter 2026 financial results and provided a corporate update. The company announced that its EVERLAST-B Phase 2b trial for ORKA-001 is fully enrolled, with Week 16 data expected in the fourth quarter of 2026 to support a Phase 3 program starting in early 2027. Additionally, the ORCA-SURGE trial for ORKA-002 has accelerated, with Week 16 data now expected in the first quarter of 2027. The company initiated the ORCA-SPLASH Phase 2 trial for ORKA-002 in hidradenitis suppurativa and announced that its novel antibody ORKA-004 will enter clinical trials in the fourth quarter of 2026. Financially, Oruka reported a net loss of $41.2 million and held $1.1 billion in cash, which is expected to fund operations through an anticipated BLA filing for ORKA-001. The company operates as a clinical-stage biotechnology firm developing biologics for chronic skin diseases.