Oruka reports Q2 2026 results, advances ORKA-001 and ORKA-002 programs

Oruka Therapeutics reported second quarter 2026 results and a pipeline update on August 10, 2026. In April 2026 the company presented positive data from its EVERLAST-A Phase 2a trial in moderate-to-severe plaque psoriasis, with 40 of 63 (63.5%) participants treated with ORKA-001 achieving PASI 100 at Week 16, along with PASI 90 in 83% of treated participants and IGA 0/1 in 84%, with a safety profile the company described as similar to placebo and consistent with prior IL-23p19 inhibitors.¹

Oruka said it plans to report Week 28 data from EVERLAST-A for all participants near the end of the third quarter of 2026, which will give an early look at how long responses hold up over six months and whether responses deepen among patients who had not reached PASI 100 by Week 16.¹ Oruka also expects to report 52-week data from EVERLAST-A for all participants in December 2026.¹

EVERLAST-B, a Phase 2b dose-ranging trial in moderate-to-severe psoriasis, completed enrollment of 187 subjects in the second quarter, and the company now expects Week 16 data for all participants in the fourth quarter of 2026, which it said are intended to support starting a Phase 3 program in the first half of 2027.¹

For ORKA-002, the company now expects Week 16 data from the ORCA-SURGE Phase 2 trial in moderate-to-severe psoriasis in the first quarter of 2027.¹ Oruka also initiated ORCA-SPLASH, a randomized, double-blind, placebo-controlled Phase 2 trial of ORKA-002 in about 160 patients with moderate-to-severe hidradenitis suppurativa in the United States and Canada, randomizing patients 1:1 to 320 mg of ORKA-002 or placebo at Weeks 0, 4, 8 and 12, with a primary endpoint of HiSCR75 at Week 16 followed by open-label maintenance dosing every 12 weeks.¹

The company announced ORKA-004, a subcutaneously administered, half-life extended monoclonal antibody targeting TL1A, which it expects to enter the clinic in the fourth quarter of 2026, with Phase 2 combination studies alongside ORKA-001 and ORKA-002 planned to begin in 2027.¹

In May 2026 Oruka amended its IL-23 license agreement with Paragon Therapeutics to cover all therapeutic areas, after previously excluding inflammatory bowel disease, allowing it to pursue ORKA-001 or combinations in IBD subject to certain timing restrictions on starting clinical trials.¹

As of June 30, 2026, Oruka held cash, cash equivalents and marketable securities of $1.1 billion, which the company said it expects will fund operations through an anticipated BLA filing for ORKA-001 and continued development of ORKA-002.¹ R&D expenses were $43.3 million for the quarter versus $24.1 million a year earlier, and net loss was $41.2 million compared with $24.6 million in the second quarter of 2025.¹