Short answer
Oruka Therapeutics, Inc. (ORKA) filed an 8-K current report with the SEC on April 27, 2026 reporting Item 7.01 (Regulation FD Disclosure), Item 8.01 (Other Events), Item EX-99.1 (Exhibit EX-99.2). Exhibit 99.2 accompanies the 8-K as Regulation FD disclosure.
Oruka Therapeutics, Inc. 8-K event analysis
AI summary of each reported item and its exhibits
Item 7.01 · Regulation FD Disclosure
- Exhibit 99.2 accompanies the 8-K as Regulation FD disclosure
- Excluded from incorporation by reference into Securities Act filings unless specifically referenced
- Investors should review Exhibit 99.2 for the substantive disclosed information
Item 8.01 · Other Events
- ORKA-001 achieved PASI 100 in 63.5% of treated patients versus 4.8% placebo at Week 16, with p<0.0001
- Key secondary endpoints met: PASI 90 82.5%, IGA 0/1 84.1%, and IGA 0 63.5% versus 4.8% placebo
- Favorable safety profile: no serious TEAEs or adverse-event discontinuations; TEAEs 50.8% versus 57.1% placebo
- Phase 1 data showed drug levels above effective troughs through 52 weeks after one 600 mg dose, supporting annual dosing potential
- EVERLAST-B Phase 2b continues enrollment for approximately 160 patients, with data expected in 2027
Item EX-99.1 · Exhibit EX-99.2
- ORKA-001 achieved PASI 100 in 40/63 patients, or 63.5%, at Week 16, signaling strong complete-clearance efficacy
- PASI 90 reached 83% and IGA 0/1 reached 84%, with results calculated using non-responder imputation
- Safety resembled placebo, with treatment-emergent adverse events in 51% versus 57% for placebo and no serious events
- Phase 1 PK/PD data support potential once-yearly dosing, a major convenience differentiator in psoriasis
- Week 28 data for all patients and 52-week subset follow-up expected in 2H 2026; Phase 2b data targeted for 2027
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