The U.S. FDA grants orphan drug designation for Lundbeck's investigational anti-ACTH monoclonal antibody asedebart for treatment of endogenous Cushing's syndrome

The FDA granted Orphan Drug Designation to Lundbeck's investigational anti-ACTH monoclonal antibody asedebart (Lu AG13909) for endogenous Cushing's syndrome, a rare endocrine disorder typically driven by excess ACTH. The designation supports development of the potential treatment for a high-unmet-need rare disease and may provide regulatory and commercial incentives, though the drug remains investigational.