Kedrion SpA received European orphan drug designation from the EMA for its plasma-derived investigational therapy targeting congenital aceruloplasminemia. The designation supports Kedrion’s plans to progress the program toward clinical development in Europe and may provide regulatory and market incentives such as protocol assistance and market exclusivity. Kedrion intends to advance manufacturing and clinical planning for a condition with very limited treatment options; orphan status can ease development hurdles and attract clinical collaborators focused on rare neurologic–metabolic disorders.