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Cue Biopharma's CUE-221 Shows Robust CSU Efficacy; Phase 2b/3 Planned

Sep 21, 2026, 11:10 AM EDT1 sourcesAI-analyzed

Why it may matterVerify against the original reporting

Strong efficacy signals and a clearly defined Phase 2b/3 path can re-rate the stock on a longer horizon; near-term price may be buoyed by progression news, though initial reaction has been mixed due to market sensitivity to biotech timing and potential dilution.

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What happened, with direct paths to the underlying reporting

Cue Biopharma reported topline Phase 2 results for CUE-221 in chronic spontaneous urticaria, showing robust efficacy and a favorable safety profile. The 4 mg/kg dose achieved 54% complete hive resolution at Week 12, with benefits persisting through Week 28 off-drug and a 36% advantage over omalizumab. Management plans a Phase 2b/3 CSU trial alongside a Phase 2 food allergy study, signaling a clear near-term development catalyst.

Phase 2 topline: CUE-221 meets primary and secondary CSU endpoints.
Week 12: 4 mg/kg yields 54% hive resolution vs 11% placebo.
Week 22 peak: 69% complete resolution in 4 mg/kg group.
Week 28 off-drug: 36% advantage vs omalizumab.
Phase 2b/3 CSU trial and Phase 2 food allergy study planned; safety favorable.

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