Cue Biopharma Shares Jump 41.6% Premarket Following Phase 2 Trial Results

Cue Biopharma (NASDAQ:CUE) shares rose 41.6% in premarket trading after the company reported positive topline results from a Phase 2 clinical trial evaluating CUE-221 in patients with moderate to severe chronic spontaneous urticaria.

The investigational anti-IgE monoclonal antibody is being developed to treat a condition characterised by recurring hives that can significantly affect patients’ quality of life.

The study, conducted in China by Genesis Life Sciences, enrolled 145 patients whose symptoms remained inadequately controlled despite treatment with standard antihistamines.

Trial Meets Primary and Key Secondary Endpoints

Cue Biopharma reported that the trial met its primary endpoint and a key secondary endpoint with high statistical significance. The company also described the treatment’s safety profile as favourable.

According to the reported findings, CUE-221 demonstrated an efficacy profile that differed from omalizumab, marketed as Xolair, an established treatment for chronic spontaneous urticaria.

The company indicated that the results could support a potential clinical advantage for CUE-221, although the available topline information does not establish superiority over omalizumab.

The findings could provide a basis for advancing the drug into a Phase 2b/3 study intended to support a potential regulatory application.

Further clinical data and regulatory discussions will be needed to determine the next development steps.

Analyst Coverage and Broader Market Gains Provide Context

The clinical announcement followed B. Riley Securities’ initiation of coverage of Cue Biopharma several days earlier with a Buy rating.

Broader US equity markets were also trading higher, with the Nasdaq up 0.9% and the S&P 500 gaining 0.6%.

Cue Biopharma’s shares moved above their previously reported 52-week high of $45.50 during premarket trading.

The company scheduled a conference call for 8:00 a.m. EDT to discuss the trial results and provide further information about the development programme.

Investors will be looking for additional details on the magnitude and durability of treatment responses, safety findings and the proposed design of the next clinical study.

Cue Biopharma stock price