The designation follows a positive opinion from the Committee for Orphan Medicinal Products (COMP) of the European Medicines Agency (EMA).

Orphan medicinal product designation by the EC may provide certain development and commercial incentives, including protocol assistance, fee reductions, and, if approved, up to 10 years of market exclusivity. Criteria for designation include the potential to provide significant benefit to patients affected by the condition.

"Patients with unresectable or metastatic GEP-NETs often face a complex treatment journey, with limitations in currently available treatment options," said Thijs Spoor, Perspective’s CEO. "The European orphan designation for [²¹²Pb]VMT-α-NET provides important incentives to support its development in Europe, reflects the need for additional therapeutic options for European patients living with GEP-NETs, and advances our broader goal of developing next-generation targeted radiopharmaceuticals."

GEP-NETs are a heterogeneous group of tumors that arise from neuroendocrine cells throughout the gastrointestinal tract and pancreas. Although uncommon, their incidence and prevalence have increased substantially over the past several decades, driven in part by improved diagnostic techniques and greater disease awareness. Patients with GEP-NETs continue to face important treatment gaps, including delayed diagnosis due to nonspecific symptoms and limited durable disease control with available therapies, particularly in advanced or metastatic disease.