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Home » FDA grants orphan drug designation to Amphix Bio’s AMFX-200
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Neurology/psychiatric

FDA grants orphan drug designation to Amphix Bio’s AMFX-200

July 17, 2025
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Amphix Bio LLC has been granted U.S. FDA orphan drug designation for its lead candidate AMFX-200 for the treatment of acute spinal cord injury (SCI). AMFX-200 is an FGFR (fibroblast growth factor receptor) and ITGB1 (integrin β1) agonist peptide amphiphile scaffold. In preclinical models of acute SCI, a single injection of AMFX-200 into the spinal cord enabled motor neurons from the brain to regrow past the injury site.
BioWorld Science Regulatory Neurology/psychiatric FDA Orphan drug

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