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Oruka Therapeutics Stock Rises 14.3% to $91.62
Oruka Therapeutics is up 14.3%, or $11.47 to $91.62.
Oruka Therapeutics Stock Rises 11.6% to $89.44
Oruka Therapeutics is up 11.6%, or $9.29 to $89.44.
Oruka Therapeutics Reports Week 16 Results for ORKA-001
Oruka Therapeutics announced Week 16 results from its EVERLAST-B Phase 2b trial of ORKA-001, a half-life extended IL-23p19 monoclonal antibody, in moderate-to-severe PsO. Efficacy increased in a dose-dependent manner across ORKA-001 treatment groups, with the high-dose group outperforming both lower dose groups on complete skin clearance. 61% of patients in the high-dose group achieved the primary endpoint of PASI 100 at Week 16, compared to 0% of patients receiving placebo. The ORKA-001 high-dose group demonstrated high response rates across secondary endpoints, including 86% of patients achieving PASI 90 and IGA 0/1, consistent with the results observed in EVERLAST-A. ORKA-001 continues to be well tolerated, with a safety profile consistent with the IL-23p19 class. The overall rate of treatment-emergent adverse events, or TEAEs, was comparable across groups, with 39% of patients in the high-dose group experiencing at least one TEAE, versus 43% of participants receiving placebo. The only TEAEs occurring in greater than or equal to5% of patients treated with ORKA-001 were upper respiratory tract infection and headache, occurring at rates similar to those seen with approved IL-23 inhibitors. No dose-dependent trends in adverse events were observed across ORKA-001 treatment groups, and no injection-site reactions occurred in any patients who received ORKA-001. No serious TEAEs occurred in the high-dose group. Serious TEAEs occurring in the other groups were kidney stones, miscarriage, psoriasis, substance-induced psychotic disorder, and syncope following a blood draw and jaw fracture. None were considered treatment related.
Oruka Therapeutics Reports Positive Week 28 Results for ORKA-001
Oruka Therapeutics announced positive Week 28 results from its EVERLAST-A Phase 2a trial of ORKA-001, a novel half-life extended IL-23p19 monoclonal antibody, in moderate-to-severe plaque psoriasis. Key highlights: PASI 100 increased to 71.4% and PASI 90 increased to 87.3%, despite no dosing after Week 4; Placebo crossover patients reached PASI 100 and PASI 90 rates similar to those initially dosed with ORKA-001; ORKA-001 maintained a favorable safety and tolerability profile through Week 28; 52-week EVERLAST-A data for all patients expected in December 2026; 16-week EVERLAST-B data expected in 4Q 2026. "These Week 28 results, with responses continuing to deepen months after the last dose, point to the incredible potential of ORKA-001," said Joana Goncalves, MBChB, Chief Medical Officer of Oruka. "With over 70% of patients achieving completely clear skin after just two induction doses and a safety profile consistent with the IL-23 class, ORKA-001 has the potential to redefine the standard of care for psoriasis. We look forward to sharing the full 52-week data later this year."
Oruka Therapeutics Appoints Todd Edwards as Chief Commercial Officer
Oruka Therapeutics (ORKA) announced the appointment of Todd Edwards as chief commercial officer, effective August 24. Edwards joins Oruka from Arcutis Biotherapeutics (ARQT), where he served as executive VP and chief commercial officer.
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