Oruka Therapeutics, Inc. ORKA
Oruka Therapeutics, Inc. (Nasdaq: ORKA) is a dermatology drug developer. Its lead program, ORKA-001, is in Phase 2 for moderate-to-severe plaque psoriasis (EVERLAST-A Phase 2a, EVERLAST-B Phase 2b). Its next catalyst on record is ORKA-001: Oruka expects to share 52-week results from EVERLAST-A trial of ORKA-001 in December 2026. (December 2026).
Upcoming catalysts
- December 2026ORKA-001 — Oruka expects to share 52-week results from EVERLAST-A trial of ORKA-001 in December 2026.
Oruka expects to share 52-week results from EVERLAST-A in December 2026.
- December 2026ORKA-001 (IL-23p19 inhibitor) — Oruka expects to report 52-week results from EVERLAST-A in December 2026.
In addition, Oruka expects to share 52-week results from EVERLAST-A in December 2026, as well as 52-week results from EVERLAST-B in the second half of 2027.
- December 2026ORKA-001 (half-life extended IL-23p19 mAb) — Oruka expects to report 52-week results from EVERLAST-A trial of ORKA-001 in December 2026.
Oruka expects to share 52-week results from EVERLAST-A in December 2026.
Next further out: ORKA-004 — Initiate clinical development (anti-TL1A) (Q4 2026). 14 catalysts on record beyond the next 30 days; subscribers see each with its filing sentence.
Pipeline
| Program | Indication | Modality | Stage |
|---|---|---|---|
| ORKA-001 (extended half-life anti-IL-23p19 mAb) | psoriasis (Phase 2a EVERLAST-A: Week 16 PASI 100 in 40 of 63 treated; Phase 2b EVERLAST-B enrolled 187) | antibody | Phase 2 |
| ORKA-002 (extended half-life anti-IL-17A/F mAb) | psoriasis (ORCA-SURGE Phase 2, ~160 pts, started Feb 2026) | antibody | Phase 2 |
| ORKA-002 | hidradenitis suppurativa (ORCA-SPLASH Phase 2, ~160 pts) | antibody | Phase 2 |
| ORKA-004 (anti-TL1A mAb) | combination with ORKA-001/002 in I&I diseases | antibody | Pre-clinical |
| ORKA-003 | undisclosed pathway | antibody | Pre-clinical |
Recent results and decisions
- Oct 26, 2026met ORKA-001 high dose achieved 61% PASI 100 and 86% PASI 90 at Week 16 in the EVERLAST-B Phase 2b trial, meeting the primary endpoint.
61% of patients in the high-dose group achieved the primary endpoint of PASI 100 at Week 16, compared with 0% of patients receiving placebo (p<0.0001).
Filing - Oct 26, 2026met ORKA-001 achieved primary endpoint of 61% PASI 100 at Week 16 in EVERLAST-B Phase 2b trial in psoriasis.
61% PASI 100 and 86% PASI 90 in ORKA-001 600 mg group at Week 16, consistent with EVERLAST-A
Filing - Oct 26, 2026n/a Oruka plans to initiate Phase 3 trials of ORKA-001 in moderate-to-severe psoriasis in the first half of 2027.
Oruka plans to initiate Phase 3 trials of ORKA-001 in moderate-to-severe PsO in the first half of 2027, with the High Dose (600 mg), subject to regulatory interactions.
Filing
4 more on record.
For subscribers
- Cash runway against each catalyst, with the company's own runway statement
- Track record: every Phase 3 readout, FDA decision and guidance slip since 2014
- Expected move for each dated catalyst, from comparable past events
- Phase 2 evidence behind each Phase 3 readout
- Companies on the same target or class
- Full catalyst list with filing sentences, deals, registered trials, Excel export
Other phase 2 dermatology companies
The free Monday brief
Last week's readouts and FDA decisions and the dated catalysts in the week ahead, each with its filing sentence.