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By Editor , 17 September 2026

FDA Grants Orphan Drug Status to Lundbeck's Cushing's Antibody Asedebart

Valby, Denmark – – September 16, 2026 -- The U.S. Food and Drug Administration has granted Orphan Drug Designation to asedebart (Lu AG13909), Lundbeck's investigational anti-ACTH monoclonal antibody, for the treatment of endogenous Cushing's syndrome.

asedebart