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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.
研报英文原文证据摘录
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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