CUE, US22978P2056

Cue Biopharma reports CUE-221 hives data: what it means for Cue Biopharma stock

Published on 10/07/2026 at 03:16 | Editorial responsibility: Rafael Müller, Editor-in-Chief AD HOC NEWS

CUE-221 produced 54.00 percent hive resolution at week 12 versus 11.00 percent placebo. For Cue Biopharma stock this means a planned Phase 2b/3 study.

CUE, US22978P2056, Illustration mit AI erstellt.

Cue Biopharma (ISIN US22978P2056) reported CUE-221 Phase 2 hives data on September 20, 2026, with complete hive resolution reaching 54.00 percent at week 12 versus 11.00 percent for placebo. The company said the results support advancing CUE-221 into a Phase 2b/3 study for chronic spontaneous urticaria, as detailed by Cue Biopharma.

Phase 2 results sharpen the next test

The randomized study enrolled 145 participants with moderate to severe chronic spontaneous urticaria and compared three CUE-221 doses with placebo and omalizumab. At the highest dose, 46.00 percent of participants achieved complete response on the UAS7 measure at week 12, versus 11.00 percent on placebo.

The durability signal is central to the development case. At week 28, twelve weeks after dosing ended, complete hive resolution stood at 60.00 percent for the 4 mg/kg group versus 24.00 percent for omalizumab, a reported 36.00 percentage-point difference.

What the data means for development

The trial was designed to test superiority over placebo, while the omalizumab comparison was not planned as a statistical test. That distinction matters because the 36.00 percentage-point week-28 difference is a post hoc comparison rather than a head-to-head superiority result.

StockTitan reported that collaboration revenue rose to USD 7.90 million in the second quarter of 2026 from USD 3.00 million a year earlier. The company recorded a net loss of USD 153.10 million, versus USD 8.50 million in the second quarter of 2025, and held USD 17.40 million in cash as of June 30, 2026.

Nasdaq valuation keeps a wide range

The finance quote showed CUE last at USD 23.14 on Nasdaq on October 6, 2026 at 4:00 p.m. EDT, with a 52-week range of USD 4.97 to USD 45.50 and market capitalization of USD 168.10 million. The prior close at Lang & Schwarz was EUR 20.63 on October 5, 2026. The further course of trading is shown by the continuously updated real-time quote of Cue Biopharma stock.