Cue Biopharma said its Phase 2 trial in chronic spontaneous urticaria (CSU) met key endpoints with CUE-221, its humanized anti-IgE IgG1 monoclonal antibody designed for a dual mechanism involving free IgE binding and preservation of CD23 signaling. The study, conducted in China by Genesis Life Sciences, enrolled 145 patients with moderate to severe CSU. Cue reported that the primary endpoint—hives severity score over seven days (HSS7)—and a key secondary endpoint—complete response on the urticaria activity score over seven days (UAS7=0)—were achieved with high statistical significance, alongside a favorable overall safety profile. Despite the reported efficacy, the company’s shares fell sharply, highlighting how investors are balancing early clinical progress against the financing and competitive expectations for an eventual Phase 2b/3 program.