Oruka reports positive Week 16 psoriasis data and plans Phase 3 development

Oruka Therapeutics reported October 26 Week 16 results from the Phase 2b EVERLAST-B study of ORKA-001 in adults with moderate-to-severe plaque psoriasis. In the 600 mg group, 61% of patients reached PASI 100 and 86% reached PASI 90. Oruka plans to discuss Phase 3 development with regulators and targets starting Phase 3 trials in the first half of 2027.

The results provide clinical support for advancing ORKA-001 toward Phase 3, although regulatory discussions and longer-term durability data remain ahead. Guggenheim reiterated a Buy rating and a $200 price target, citing the trial results, according to the material.

  • 1EVERLAST-B was a randomized, double-blind, placebo-controlled Phase 2b study involving 187 patients across 36 sites.
  • 2At Week 16, 61% of patients receiving 600 mg achieved PASI 100 and 86% achieved PASI 90.
  • 3The company reported no serious or severe side effects in the 600 mg group through Week 16.
  • 4Oruka expects Week 52 data from the separate EVERLAST-A study in December.
  • 5The company plans to advance the 600-milligram dose into Phase III, with initiation targeted for the first half of 2027.
  • Oruka has not finalized the Phase 3 trial design or active comparator choice.
  • The company's proposed annual maintenance schedule still depends on later durability data and further trials.

Sources