Cue Biopharma reports positive Phase 2 topline results for CUE-221 in urticaria
Cue Biopharma announced positive topline results from a Phase 2 trial of CUE-221 in chronic spontaneous urticaria (CSU), conducted in China by Genesis Life Sciences with 145 participants. The primary endpoint was met at all dose levels, and the company plans a Phase 2b/3 CSU trial and a Phase 2 food allergy trial, subject to FDA review of the Phase 2 data. The filing contains clinical data only, with no revenue, earnings, cash or financing figures.
Key points
- Primary endpoint (complete resolution of hives, HSS7=0, at week 12): 54% at 4 mg/kg, 53% at 2 mg/kg and 43% at 1 mg/kg, vs. 11% for placebo and 41% for omalizumab 300 mg.
- Key secondary endpoint (UAS7=0 at week 12) was statistically significant at 4 mg/kg: 46% vs. 11% for placebo.
- At week 28, 12 weeks off drug, complete resolution of hives was 60% at 4 mg/kg vs. 24% for omalizumab, a 36% difference (post hoc analysis).
- No treatment-related serious adverse events and no hypersensitivity reactions, including anaphylaxis, were reported; the company will present full data at an upcoming scientific meeting.
The filing
Written by AI on Nov 9, 2026, 8:53 AM ET, from this filing only. Written later: this filing was briefed after the fact, when past filings were added to the site, so the brief may be read with hindsight; the filing itself is the record of what was known on September 21, 2026.
Briefs are written by AI from the filing text and can contain mistakes — open the filing before acting on anything. Impact (1-5) and tone are the AI's reading of the filing for shareholders, not a price forecast. Not investment advice.