EMA Grants Orphan Status to Kiadis Pharma's Immuno-oncology Molecule

The European Medicines Agency granted an orphan status to ATIR, a T-cell immunotherapy-based medicinal product being developed to treat blood cancers.

Kiadis Pharma B.V. ("Kiadis Pharma" or "the Company"), a clinical stage biopharmaceutical company developing T-cell immunotherapy treatments for blood cancers, today announces that its lead product ATIR™ has been granted Orphan Drug Designation (ODD) by the European Medicines Agency (EMA) for the treatment of acute myeloid leukemia (AML). Kiadis Pharma has previously been granted an ODD for ATIR™ by both the EMA and the FDA for the prevention of acute Graft versus Host Disease (GvHD) following an allogeneic bone marrow transplantation.

The EMA's ODD is reserved for new therapies being developed to treat life-threatening or chronically debilitating diseases or conditions that are relatively rare in the European Union and for which no satisfactory therapy is available. The ODD designation provides for incentives to support development, including fee reductions and a ten-year period of market exclusivity in the European Union after product approval.

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