Cue Biopharma reported positive topline results from a Phase 2 trial of in-licensed CUE-221 in 145 patients with moderate to severe chronic spontaneous urticaria, or recurring hives without a known trigger. Conducted by Genesis Life Sciences in China, the study tested subcutaneous doses of 4 mg/kg, 2 mg/kg and 1 mg/kg every four weeks against placebo and omalizumab. At Week 12, complete hive resolution reached 54% with the 4 mg/kg dose versus 11% for placebo, and all three doses outperformed placebo, meeting the primary endpoint. The 4 mg/kg group also achieved a statistically significant 46% complete response rate on the key secondary endpoint. The peak effect came at Week 22, when 69% of patients receiving 4 mg/kg had complete resolution, with benefits continuing through Week 28, or 12 weeks after the final dose at Week 16. At Week 28, CUE-221 showed a statistically significant 36% efficacy advantage over omalizumab. Cue Biopharma is preparing a Phase 2b/3 chronic-hives trial and advancing a Phase 2 food-allergy study. No treatment-related serious adverse events or anaphylaxis were reported. Shares initially rose Monday before falling 28.53% to $26.48 at publication, although a separate roundup described the decline as nearly 25%.