Amphix Bio Receives FDA Orphan Drug Designation for Neural Regeneration Therapeutic to Treat Acute Spinal Cord Injury

Amphix Bio receives FDA Orphan Drug Designation for neural regeneration therapeutic to treat acute spinal cord injury

CHICAGO, July 16, 2025 /PRNewswire/ -- Amphix Bio, a pre-clinical stage company developing a new therapeutic modality for regenerative medicine, received an Orphan Drug Designation from the U.S. Food and Drug Administration (FDA) for its lead candidate AMFX-200 for treatment…

‘Dancing molecules’ treatment receives FDA Orphan Drug Designation

The therapy harnesses molecular motion to reverse paralysis and repair tissues after traumatic spinal cord injuries. The FDA’s Orphan Drug program is designed to encourage and support the development of treatments for rare diseases or conditions.