Cue Biopharma says CUE-221 Phase 2 trial in chronic spontaneous urticaria meets primary endpoint

Full results, including pharmacokinetic and IgE analyses, will be presented at a future scientific meeting. An investor call is set for Sept. 21.

Cue Biopharma reported positive topline Phase 2 results for CUE-221 in chronic spontaneous urticaria, meeting primary and key secondary goals.

Responses strengthened beyond the main assessment window, with benefit persisting for months in the highest-dose group following treatment completion.

Results suggested a different efficacy pattern versus Xolair, supporting a potential mechanism-based differentiation with strategic implications for positioning.

The safety profile appeared favorable, with no treatment-related serious events reported and no anaphylaxis observed in the study.