Cue Biopharma said its chronic spontaneous urticaria program—an Xolair challenger candidate—hit a Phase 2 primary endpoint in a China study. The positive midstage outcome supports moving the drug into Phase 2b/3 development. Cue’s update is notable because it marked the company’s first clinical data since pivoting from oncology into immunology, aiming to capture a large, underserved patient segment with durable symptom control needs. If Phase 2b/3 confirms efficacy and differentiators versus existing biologics, Cue could intensify competitive pressure in the chronic hives market where Omalizumab remains a benchmark.