ORKA-001 - (EVERLAST-A)

Aug. 10, 2026: Oruka Therapeutics (NASDAQ: ORKA) provided a pipeline update highlighting multiple upcoming dermatology catalysts. For ORKA-001, a half-life extended IL-23p19 antibody in moderate-to-severe plaque psoriasis, April 2026 Phase 2a EVERLAST-A data showed 40/63 patients (63.5%) achieved PASI 100 at Week 16; PASI 90 was 83% and IGA 0/1 was 84%, with safety described as similar to placebo and consistent with prior IL-23p19 inhibitors. Week 28 EVERLAST-A data are expected at the end of 3Q 2026, 52-week data in December 2026, and EVERLAST-B Phase 2b Week 16 data in 4Q 2026 after full enrollment of 187 subjects; these are intended to support a Phase 3 start in 1H 2027.

For ORKA-002, a half-life extended IL-17A/F antibody, ORCA-SURGE Phase 2 Week 16 psoriasis data are now expected in 1Q 2027. The company also initiated ORCA-SPLASH, a randomized, double-blind, placebo-controlled Phase 2 trial in about 160 patients with moderate-to-severe hidradenitis suppurativa; the primary endpoint is HiSCR75 at Week 16.

Oruka also said ORKA-004, a half-life extended TL1A antibody, is expected to enter the clinic in 4Q 2026, with Phase 2 combination studies planned in 2027. Cash and securities totaled $1.1 billion as of June 30, 2026, which the company said should fund operations through an anticipated BLA filing for ORKA-001.