Cue Biopharma said its chronic spontaneous urticaria program cleared a Phase 2 primary endpoint, advancing the company’s Xolair-challenger plans to a Phase 2b/3 study. The update follows Cue’s earlier strategic shift from oncology into immunology, with this midstage readout serving as its first clinical datapoint since the pivot. In chronic hives, differentiation depends heavily on response durability, subgroup performance, and safety across longer exposure windows. Cue’s ability to reach and exceed Phase 2 expectations strengthens the case for competitive entry. The company’s next step will be translating a single Phase 2 result into a broader confirmatory strategy that addresses payer and guideline expectations tied to established anti-IgE benchmarks.
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