Lundbeck's Asedebart Gets US FDA Orphan Drug Designation for Endogenous Cushing's Syndrome

05:02 AM EDT, 09/11/2026 (MT Newswires) -- Danish biopharmaceutical company H. Lundbeck (HLUN-A.CO) said Friday it secured the US Food and Drug Administration's orphan drug designation for asedebart to treat endogenous Cushing's syndrome. The investigational monoclonal antibody targets adrenocorticotropic hormone, or ACTH, and is being developed for ACTH-dependent Cushing's syndrome. Proof-of-concept trials are underway in Cushing's disease and classic congenital adrenal hyperplasia to assess its efficacy and safety. Asedebart has also received orphan designation in the European Union for endogenous Cushing's syndrome, as well as previous orphan designations for congenital adrenal hyperplasia in the US, EU and Japan and for Cushing's disease in Japan. Asedebart is an investigational compound and is not approved for marketing by any regulatory authority.