Oruka Therapeutics: ORKA-001 high dose reaches 61% PASI 100 at Week 16 in Phase 2b trial
Oruka Therapeutics reported Week 16 results from its Phase 2b EVERLAST-B trial of ORKA-001 in moderate-to-severe plaque psoriasis. In the 600 mg group, 61% of patients reached PASI 100, the primary endpoint, versus 0% on placebo (p<0.0001), and the company plans to start Phase 3 trials in the first half of 2027 using that dose. The company also reported that cash, equivalents and marketable securities were $1.1 billion as of June 30, 2026.
Key points
- 61% of high-dose (600 mg) patients achieved PASI 100 at Week 16, versus 0% on placebo (p<0.0001); 86% achieved PASI 90 and IGA 0/1.
- Treatment-emergent adverse events occurred in 39% of high-dose patients and 43% of placebo patients; no serious TEAEs occurred in the high-dose group.
- Phase 3 trials are planned to start in the first half of 2027 with the 600 mg dose, subject to regulatory interactions.
- 52-week EVERLAST-A results are expected in December 2026; cash of $1.1 billion as of June 30, 2026 is expected to fund operations through an anticipated BLA filing.
The filing
Written by AI on Nov 9, 2026, 8:29 AM ET, from this filing only. Written later: this filing was briefed after the fact, when past filings were added to the site, so the brief may be read with hindsight; the filing itself is the record of what was known on October 26, 2026.
Briefs are written by AI from the filing text and can contain mistakes — open the filing before acting on anything. Impact (1-5) and tone are the AI's reading of the filing for shareholders, not a price forecast. Not investment advice.