CUE-221 Phase 2 CSU Data: 54% Complete Hives Resolution vs 11% Placebo, Durable 12 Weeks Off Drug
CUE has more than doubled off its 52-week low of $4.971 on elevated volume (2.2× avg).
Summary
Cue Biopharma reported positive Phase 2 topline data for CUE-221 in chronic spontaneous urticaria, with 54% complete hives resolution at the 4 mg/kg dose versus 11% placebo, durable benefit 12 weeks off drug, and a clean safety profile.
Key Events · Product Development and Regulatory · CUE
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Primary Endpoint Met with High Significance
HSS7=0 at Week 12 was 54% (4 mg/kg), 53% (2 mg/kg), and 43% (1 mg/kg) vs 11% placebo (p<0.005 for 4 and 2 mg/kg; p<0.05 for 1 mg/kg).
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Durable Benefit 12 Weeks Off Drug
HSS7=0 peaked at 69% at Week 22 for 4 mg/kg and remained 60% at Week 28 (12 weeks after last dose), a statistically significant 36-point delta vs omalizumab (24%, p<0.05).
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Clean Safety Profile
No treatment-related serious adverse events, no anaphylaxis, and only one injection site reaction > grade 1 across all CUE-221 dose groups.
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Regulatory Path Forward
IND submitted to FDA for food allergy; company plans Phase 2b/3 in CSU and Phase 2 in food allergy, subject to FDA review of the Phase 2 CSU data.
Analysis · CUE · Life Sciences
The full Phase 2 dataset for CUE-221 in chronic spontaneous urticaria, disclosed in Cue Biopharma's 8-K, delivers striking numbers. At the 4 mg/kg dose, 54% of patients achieved complete resolution of hives (HSS7=0) at Week 12 versus 11% on placebo — a 43-point absolute difference with p<0.005. The effect peaked at 69% at Week 22 and, critically, remained at 60% twelve weeks after the last dose, while omalizumab fell to 24%. That 36-point delta at Week 28 (p<0.05) is the first clinical evidence supporting the dual mechanism of action — CUE-221 not only neutralizes IgE but preserves CD23 binding to suppress new IgE synthesis. Safety was clean: no treatment-related serious adverse events, no anaphylaxis. Against a backdrop of $17.4M in cash and a going-concern warning from the last 10-Q, this dataset materially de-risks the lead asset and strengthens the company's ability to raise capital or attract a partner. The stock is already up 51% premarket to $56.00, reflecting the market's immediate repricing.
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At the time of this filing, CUE was trading at $47.67 on NASDAQ in the Life Sciences sector, with a market capitalization of approximately $269.1M. The 52-week trading range was $4.97 to $45.50. This filing was assessed with positive market sentiment and an importance score of 9 out of 10.