Poxel S.A. announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation (FTD) to PXL065 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 that is preparing to enter into a Phase 2a clinical Proof-of-Concept (POC) biomarker study midyear. The Phase 2a clinical POC biomarker study for PXL065 in X-linked ALD is anticipated to begin midyear, followed by results in early 2023.
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- Poxel Announces PXL065 Granted FDA Fast Track Designation for X-Linked Adrenoleukodystrophy