Cue Biopharma's CUE-221 Hits Primary Endpoint in Phase 2 CSU Trial, Beats Xolair
CUE has more than doubled off its 52-week low of $4.971 on elevated volume (2.2× avg).
Summary
Cue Biopharma announced positive topline results from its Phase 2 trial of CUE-221 in chronic spontaneous urticaria (CSU). The primary endpoint, complete resolution of hives (HSS7=0) at week 12, was met with statistical significance at all dose levels (p<0.005 for 4 mg/kg and 2 mg/kg; p<0.05 for 1 mg/kg), with rates of 54% for 4 mg/kg, 53% for 2 mg/kg, and 43% for 1 mg/kg versus 11% placebo and 41% omalizumab. The key secondary endpoint, complete response (UAS7=0), was also met at the highest dose, with a rate of 46% for 4 mg/kg. Notably, the 4 mg/kg dose showed a 36% absolute improvement over omalizumab (Xolair) at week 28, 12 weeks after the last dose, suggesting a durable, mechanism-based advantage. Safety was favorable with no treatment-related serious adverse events. The company plans to advance CUE-221 into a Phase 2b/3 registration-enabling study in CSU and a Phase 2 study in food allergy. This is a major clinical catalyst for a company with a market cap of only $269 million and a cash runway of roughly two quarters based on the $17.4 million reported in August. The data validate the dual-mechanism anti-IgE approach and position CUE-221 as a potential best-in-class therapy in a market dominated by Xolair. A conference call is scheduled for Monday, September 21 at 8:00 a.m. EDT to discuss the results.
Updated with an SEC 8-K filing · What changed
Updates
· SEC 8-K — The 8-K includes the full press release and slide presentation; primary endpoint HSS7=0 at week 12 was 54% for 4 mg/kg, 53% for 2 mg/kg, 43% for 1 mg/kg vs 11% placebo and 41% omalizumab; UAS7=0 was 46% for 4 mg/kg.
At the time of this announcement, CUE was trading at $37.63 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 news item was assessed with positive market sentiment and an importance score of 9 out of 10. Source: GlobeNewswire.