Cue Biopharma's shares rallied ahead of the opening bell following positive results in a trial of a prospective treatment for spontaneous urticaria, a disease that results in chronic hives.

In premarket trading, the biopharmaceutical company's shares were 51% higher at $56.00. As of Friday's close, the stock had already climbed 84% over the last 12 months.

Cue said that due to the results from a Phase 2 clinical trial conducted in China by Genesis Life Sciences, a related company of privately held Ascendant Health, it is working toward the rapid initiation of a Phase 2b/3 study and continuing to advance a planned Phase 2 study in food allergy.

The study of CUE-221, which enrolled 145 participants with moderate to severe chronic spontaneous urticaria, met its primary endpoint and the key secondary endpoint was met with high statistical significance, Cue said. It said CUE-221 demonstrated an overall favorable safety profile.

The multicenter, randomized, double-blind, placebo and active comparator-controlled study was designed to test superiority over placebo.

CUE-221, also known as UB-221, was originally developed by United Biopharma with rights allocated between two of its related companies, Genesis Life Sciences and Ascendant Health. Under an exclusive license agreement with Ascendant, Cue obtained exclusive development, manufacturing, and commercialization rights in Ascendant's rest-of-world territories that exclude China, Hong Kong, Macau and Taiwan.