secwatch.observer — SEC 8-K summary
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Issuer:     Cue Biopharma, Inc. (CUE)
CIK:        0001645460
Form:       8-K
Filed at:   2026-09-21T12:00:17+00:00
Accession:  0001193125-26-396094
Event type: other_material
Sentiment:  positive
Materiality: 0.85
Item codes: 7.01, 8.01, 9.01
LLM model:  deepseek-v4-flash:cloud@v2

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

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1645460/000119312526396094/0001193125-26-396094-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1645460/000119312526396094/d21238d8k.htm
  HTML page:      https://secwatch.observer/filing/0001193125-26-396094

License: Source filings: public domain (SEC EDGAR). Summaries (headline + bullets): CC-BY-4.0; attribute https://secwatch.observer