Cue Biopharma's potential Xolair challenger passes Phase 2 chronic hives trial

Cue Biopharma reported Sunday that its chronic hives candidate met its goals in a mid-stage trial, the company’s first clinical data since it pivoted its focus from cancer to immunology, according to Endpoints News.

The Phase 2 study, conducted in China, tested the drug in patients with chronic spontaneous urticaria, according to the report. The trial results represent an early proof point for Cue’s redirected pipeline, which the company had reoriented away from oncology programs toward immune-mediated conditions.

Endpoints News framed the drug as a potential challenger to Xolair (omalizumab), the Genentech and Novartis antibody that has long dominated treatment for chronic hives patients who don’t respond to antihistamines. Xolair has held a substantial share of that market, and any credible competitor entering Phase 2 with positive data would be notable to industry watchers tracking the space.

The outlet’s report characterized this as the company’s first clinical readout following its strategic shift, positioning the trial outcome as an early signal of whether Cue’s move into immunology can produce viable clinical candidates. No further details on trial size, dosing, or specific efficacy measures were included in the available reporting.

Endpoints News did not report additional specifics on regulatory timelines or next steps for the program following this Phase 2 readout.