Cue Biopharma, Inc. CUE
Cue Biopharma, Inc. (Nasdaq: CUE) is an immunology/inflammation drug developer. Its lead program, CUE-221, is in Phase 2 for allergic diseases (chronic spontaneous urticaria Phase 2; food allergy planned). Its next catalyst on record is CUE-401: IND submission and Phase 1 start (2026).
Upcoming catalysts
No catalyst is dated to the next 30 days or to an FDA action date.
Next further out: CUE-401 — IND submission and Phase 1 start (2026). 2 catalysts on record beyond the next 30 days; subscribers see each with its filing sentence.
Pipeline
| Program | Indication | Modality | Stage |
|---|---|---|---|
| CUE-221 | chronic spontaneous urticaria (China Phase 2 run by licensor affiliate) | antibody | Phase 2 |
| CUE-101 (licensed to ImmunoScape) | HPV+ cancers | protein/peptide | Phase 2 |
| CUE-102 (licensed to ImmunoScape) | WT1-expressing cancers | protein/peptide | Phase 1 |
| CUE-221 | food allergy | antibody | Pre-clinical |
| CUE-401 | autoimmune diseases | protein/peptide | Pre-clinical |
| CUE-501 (licensed to Boehringer Ingelheim) | autoimmune B-cell depletion | protein/peptide | Pre-clinical |
Recent results and decisions
- Sep 20, 2026met Primary endpoint HSS7=0 at week 12 met at all doses (54%, 53%, 43% vs 11% placebo; p<0.005 at 4 and 2 mg/kg, p<0.05 at 1 mg/kg); UAS7=0 met at 4 mg/kg (46% vs 11%).
The primary endpoint of percentage of patients with HSS7=0 at week 12 was dose-responsive and met at all dose levels.
Filing
For subscribers
- Cash runway against each catalyst, with the company's own runway statement
- Track record: every Phase 3 readout, FDA decision and guidance slip since 2014
- Expected move for each dated catalyst, from comparable past events
- Phase 2 evidence behind each Phase 3 readout
- Companies on the same target or class
- Full catalyst list with filing sentences, deals, registered trials, Excel export
Other phase 2 immunology/inflammation companies
The free Monday brief
Last week's readouts and FDA decisions and the dated catalysts in the week ahead, each with its filing sentence.