---
schema_version: "secwatch.filing_event.v1"
accession: "0001193125-26-396094"
form_type: "8-K"
ticker: "CUE"
cik: "0001645460"
company_name: "Cue Biopharma, Inc."
filed_at: "2026-09-21T12:00:17+00:00"
generated_at: "2026-09-21T12:05:57.923659+00:00"
event_type: "other_material"
sentiment: "positive"
materiality_score: 0.85
calibrated_materiality_score: 0.85
confidence: "high"
source: SEC EDGAR
---

# Cue Biopharma: CUE-221 Phase 2 in CSU meets primary and key secondary endpoints

## Summary
- Phase 2 trial (N=145) met primary endpoint HSS7=0 at week 12 at all doses: 54% (4mg/kg) vs 11% placebo, p<0.005.
- Key secondary endpoint UAS7=0 met at 4mg/kg: 46% vs 11% placebo, p<0.05; dose-responsive.
- Safety favorable: no treatment-related SAEs or anaphylaxis; only one >grade1 injection site reaction, none led to discontinuation.
- Plans to initiate Phase 2b/3 in CSU and Phase 2 in food allergy; IND for food allergy submitted to FDA.

## SEC filing metadata
- accession: 0001193125-26-396094
- form_type: 8-K
- ticker: CUE
- cik: 0001645460
- company_name: Cue Biopharma, Inc.
- filed_at: 2026-09-21T12:00:17+00:00
- event_type: other_material
- sentiment: positive
- materiality_score: 0.85
- calibrated_materiality_score: 0.85
- confidence: high
- sec_items: 7.01, 8.01, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1645460/000119312526396094/0001193125-26-396094-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1645460/000119312526396094/d21238d8k.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001193125-26-396094
- JSON: https://secwatch.observer/filing/0001193125-26-396094.json
- Plain text: https://secwatch.observer/filing/0001193125-26-396094.txt

This AI-assisted summary is a reading aid. Review the linked SEC EDGAR filing before relying on any specific claim.