Oruka Therapeutics (ORKA) Leerink Global Healthcare Conference 2026 summary

Vision and strategy

• Focus on advancing care in psoriatic disease with ultra-long acting monoclonal antibodies targeting IL-23p19 and IL-17AF.

• Pipeline anchored by two co-lead programs, ORKA-001 and ORKA-002, modeled after current gold standards but aiming for longer dosing intervals and higher efficacy.

• Differentiation through half-life extension, targeting once-a-year and twice-a-year dosing.

• Exploring potential for off-treatment remission and higher skin clearance rates.

• Well-funded to support ongoing and planned clinical studies.

Clinical development and data

• ORKA-001 demonstrated a 100-day half-life in Phase I, the longest for a monoclonal antibody in pharma.

• Phase II EVERLAST program includes Part A (single 600mg dose) and Part B (dose range finding), both ongoing.

• Readout from EVERLAST Part A expected in the second half of the year, aiming to show efficacy and durability for annual dosing.

• PASI 100 (full skin clearance) is the primary endpoint, with equal or better efficacy to Skyrizi considered a strong outcome.

• Safety profile expected to align with other IL-23p19 inhibitors, with minimal clinical concerns.

Market outlook and commercialization

• Psoriasis market leaders Skyrizi and BIMZELX have set high efficacy standards and large sales benchmarks.

• Few new mechanisms in the pipeline; focus is on perfecting product profiles for IL-23 and IL-17 targets.

• Orals offer convenience but lag in efficacy compared to biologics; annual or semi-annual injectables seen as highly attractive.

• Market is under-penetrated, with biologics expected to gain further share as convenience and efficacy improve.

• Plans to accelerate Phase III initiation post-Part B results, aiming for a faster timeline than historical six-year benchmarks.