Zenas BioPharma Submits Obexelimab Application in Immunoglobulin G4-Related Disease

MT Newswires Live05-28

Zenas BioPharma (ZBIO) said Thursday it submitted a biologics license application to the US Food and Drug Administration for obexelimab in immunoglobulin G4-related disease, a chronic fibro-inflammatory disease affecting multiple organ systems.

Obexelimab is an investigational bifunctional monoclonal antibody designed to bind both CD19 and FcgRIIb to inhibit B cell function, the company said.

The application is based on results from a phase 3 registrational trial that showed a 56% reduction in the risk of IgG4-RD flare compared with placebo during the 52-week randomized placebo-controlled period, according to the company.

Shares of Zenas BioPharma were up more than 1% pre-bell Thursday.

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