Poxel S.A. announce that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation (ODD) to PXL065 and PXL770 for the treatment of patients with adrenomyeloneuropathy (AMN), the most common form of X-linked adrenoleukodystrophy (ALD). PXL065 is a novel, proprietary deuterium-stabilized R-stereoisomer of pioglitazone. PXL770 is a novel, first-in-class direct adenosine monophosphate-activated protein kinase (AMPK) activator. Both compounds are preparing to enter into Phase 2a clinical Proof-of-Concept (POC) biomarker studies as soon as possible, subject to financing. ODD is granted by the FDA to novel therapeutics for diseases or conditions that affect fewer than 200,000 individuals in the U.S. Orphan Drug Designation1 gives a company a potential seven-year window of exclusive marketing rights following FDA approval, along with a reduction in certain application fees, and tax credits for expenses related to qualified clinical trials conducted after orphan designation is received.