This report is based on public company disclosures, filings and announcements reviewed by GSN; figures are as stated by the company and have not been independently verified.

Cue Biopharma (Nasdaq: CUE) announced on September 20, 2026, that it has achieved positive topline results from a Phase 2 clinical trial of its drug candidate CUE-221. The trial evaluated the treatment for chronic spontaneous urticaria, a condition characterized by chronic hives that remain inadequately controlled despite standard antihistamine therapy. According to the company, the results support the potential for CUE-221 to become a differentiated therapeutic option and justify advancement to Phase 2b and Phase 3 registration-enabling studies.

The Phase 2 study was a multicenter, randomized, double-blind, placebo and active comparator-controlled trial conducted in China by Genesis Life Sciences, a related company of Ascendant Health Limited. The trial enrolled 145 participants with moderate to severe chronic spontaneous urticaria. Patients were randomized across five treatment groups to receive subcutaneous injections of CUE-221 at doses of 4 mg/kg, 2 mg/kg, or 1 mg/kg every four weeks, or placebo every four weeks, or the active comparator omalizumab at 300 mg every four weeks. The study included a 16-week treatment period followed by a 20-week follow-up period.

The primary endpoint of the study was the proportion of patients who achieved complete resolution of hives, defined as a Hives Severity Score of zero at week 12. According to the filing, this endpoint was met with high statistical significance at all dose levels of CUE-221. Specifically, 54 percent of patients in the 4 mg/kg group, 53 percent in the 2 mg/kg group, and 43 percent in the 1 mg/kg group achieved complete resolution of hives, compared to 11 percent in the placebo group. The p-values versus placebo were less than 0.005 for the two higher doses and less than 0.05 for the lowest dose.

A key secondary endpoint assessed the proportion of patients who achieved a Urticaria Activity Score of zero at week 12. This endpoint reached statistical significance at the highest dose level of 4 mg/kg, where 46 percent of patients responded compared to 11 percent in the placebo group. The company noted that the percentage of participants achieving complete resolution of hives increased beyond the primary endpoint, peaking at week 22 across all CUE-221 dose groups. Clinically meaningful benefit was maintained for up to 12 weeks off treatment at the 4 mg/kg dose level.

The company stated that a post hoc analysis at week 28 demonstrated a statistically significant difference versus omalizumab, with a 36 percent higher rate of complete resolution of hives for the 4 mg/kg dose group. The filing indicates that CUE-221 demonstrated an overall favorable safety profile with no treatment-related serious adverse events or anaphylaxis reported.

Cue Biopharma is a clinical-stage biopharmaceutical company targeting transformative therapies for immune-mediated diseases. The company said it is working toward the rapid initiation of a Phase 2b/3 study in chronic spontaneous urticaria and continues to advance a planned Phase 2 study in food allergy. The company plans to host a conference call on Monday, September 21, at 8:00 a.m. EDT to discuss the data.

For investors, these results provide critical evidence regarding the efficacy of CUE-221 in a difficult-to-treat patient population. The ability to meet primary and secondary endpoints with statistical significance supports the company’s strategy to advance the drug toward regulatory approval. The favorable safety profile and potential for durable response off-treatment may influence the commercial outlook for the asset.

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