POXEL SA announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation (FTD) to PXL770 for the treatment of patients with adrenomyeloneuropathy (AMN), the most common form of X-linked adrenoleukodystrophy (ALD). PXL770 is a novel, first-in-class direct adenosine monophosphate-activated protein kinase (AMPK) activator that is preparing to enter into a Phase 2a clinical Proof-of-Concept (POC) biomarker study midyear, subject to additional financing. The Phase 2a clinical POC biomarker studies for Poxel's two products, PXL770 and PXL065, in X-linked ALD are, subject to additional financing, anticipated to begin midyear, with results anticipated early 2023.
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- Poxel Announces PXL770 Wins FDA Fast Track Designation for X-Linked Adrenoleukodystrophy