ORKA-001 Hits 61% Complete Skin Clearance at Week 16 in Phase 2b Psoriasis Trial
ORKA has more than doubled off its 52-week low of $25.23.
Summary
Oruka's ORKA-001 posted 61% PASI 100 and 86% PASI 90 at Week 16 in the 600 mg high-dose arm of the 187-patient EVERLAST-B Phase 2b trial, versus 0% PASI 100 on placebo (p<0.0001). That replicates the EVERLAST-A result despite less than 30% site overlap between the two studies, which is the key credibility point for the program. Safety looked clean: 39% of high-dose patients had at least one TEAE versus 43% on placebo, no serious TEAEs in the high-dose group, and no injection-site reactions in any ORKA-001 patient. Management now plans to take the 600 mg dose into Phase 3 in the first half of 2027, with 52-week EVERLAST-A data due in December 2026. This lands after the September EVERLAST-A Week 28 readout that initially disappointed and knocked the stock; consistent high-dose clearance across a second trial is the argument that the profile holds.
At the time of this announcement, ORKA was trading at $78.00 on NASDAQ in the Life Sciences sector, with a market capitalization of approximately $5.3B. The 52-week trading range was $25.23 to $115.52. This news item was assessed with positive market sentiment and an importance score of 8 out of 10. Source: GlobeNewswire.