Cue Biopharma reported upbeat Phase 2 data in chronic spontaneous urticaria (CSU), with its CUE-221 candidate hitting primary and key secondary endpoints in a China-based study of 145 patients. The company said the hives severity score over 7 days (HSS7) and a complete response measure (UAS7=0) were met with high statistical significance, while safety remained overall favorable. The company is using the data to plan a Phase 2b/3 study while maintaining focus on its broader immunology strategy, following its earlier pivot away from oncology development. The reporting also triggered a sharp reaction in the stock, reflecting the market’s sensitivity to clinical data quality and next-step probability. In a separate but related report on the same CSU program, Cue’s Phase 2 results were framed as an inflection point—clearing a mid-stage hurdle that could position CUE-221 as an Xolair-like challenger if confirmatory trials uphold efficacy and durable responder rates.