普通外文研报
EHA 2026: Low-Dose Budoprutug ITP Data Show Durable Platelet Responses and Resilient Efficacy in Rituximab Failures. Additional ITP Data by YE26. Raising PT to $20.
研报英文原文证据摘录
EHA 2026: Low-Dose Budoprutug ITP Data Show Durable Platelet Responses and Resilient Efficacy in Rituximab Failures. Additional ITP Data by YE26. Raising PT to $20.
oned to expand CD19 therapy beyond Uplizna’s neurology focus. Mgmt. believes CD19 monoclonal
antibodies are still underutilized in immune-mediated diseases, creating an attractive entry opportunity particularly because
budoprutug is designed to deplete the pathogenic B cells that drive disease. Uplizna’s (inebilizumab) commercial success in rare
neuroinflammatory disease, along with its expanding development beyond neurology (e.g., Phase 3 trials in chronic inflammatory
demyelinating polyneuropathy (CIDP) and autoimmune hepatitis, and a Phase 2 study in SLE with lupus nephritis), helps identify
potential next indications for budoprutug and further validates the CD19 mAb strategy.
CLYM116 initial safety data presented at ERA provide foundation for upcoming PK/PD data. Preliminary safety data from
ongoing studies in ex-China and China in HVs (n=49) who have received up to 320mg CLYM116 doses showed no DLTs, SAEs, or
AE-related discontinuations. All AEs seen were mild/moderate (Grade 1/2), and ISRs were only seen in 2 patients (Grade 1). In
the ongoing Phase 1 SAD studies aiming to assess n = ~80 patients total, patients are expected to receive CLYM116 doses ranging
from 25mg to 640mg; there is also a multi-dose cohort where patients will receive two 320mg doses. We believe these initial
safety findings support further CLYM116 development.
CLYM116 PD modeling derived from NHP data support dose-dependent IgA suppression. A translational model suggests 640mg
CLYM116 could achieve >50% IgA reduction through 32wk, with modeled PK supporting the potential for less-frequent dosing.
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