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GLOBAL RESEARCH ARCHIVE

1Q26 - Long-Term EVERLAST-A Data in 2H26 Could Further Support ORKA-001's Best-in-Class Potential in PsO. Phase 2 Trial ORKA-002 in PsO Continues to Progress, with ORKA-002 HS Trial Planned to Begin in 2H26.

Published: 2026-05-13Institution: BTIGCompany / ticker: ORKA.OQPages: 16Original language: 英语Evidence page: 4

Research evidence excerpt

1Q26 - Long-Term EVERLAST-A Data in 2H26 Could Further Support ORKA-001's Best-in-Class Potential in PsO. Phase 2 Trial ORKA-002 in PsO Continues to Progress, with ORKA-002 HS Trial Planned to Begin in 2H26.

es with no severe TEAEs or serious AEs seen, along with no discontinuations. The only TEAEs

reported in >2 subjects were contusion, headache, skin abrasion, and upper respiratory tract infection. While oral candidiasis

could be seen in future studies, interim results show that ORKA-002's optimized PK likely does not exacerbate the AE, which we

believe is a strong positive.RESEARCH

UCB's (XBRU: UCB, Not Rated) FY25 earnings confirm Bimzelx is on a strong growth trajectory in HS, supporting a long arc for

ORKA-002. Bimzelx was approved by the FDA in HS in late November 2024 and generated ~$736M USD in HS-specific revenue

in FY25. Since launch, Cosentyx has both expanded the market and taken share from Humira, although our KOL checks indicate

that efficacy in clinical practice is generally similar between the two. Bimzelx has built upon Cosentyx's initial momentum given

its enhanced activity (18%-20% pbo corrected HiSCR50 vs. 12%-16% for Cosentyx at 16wks), supporting our expectation for

further market expansion with increased access for Bimzelx over time. HS remains a high-growth opportunity that is substantially

underpenetrated, with only two Tx classes commercially available, so we continue to see a significant opportunity for an effective

Tx option with a novel mechanism to command considerable market share and think Bimzelx's strong performance to date reads

through positively to new market entrants that are meaningfully differentiated.

ORCA-SURGE trial, in detail. This trial is a randomized, double-blind, placebo-controlled dose-ranging Phase 2 study evaluating

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