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Tag: Fast Track Designation

ReNetX Bio Receives Fast Track Designation From U.S. FDA

Published: January 8, 2020

Potential First-in-Class Therapy for Chronic Spinal Cord Injury

NEW HAVEN, Conn., Jan. 08, 2020 (GLOBE NEWSWIRE) — ReNetX Bio announced today that the U.S. Food and Drug Administration (FDA) has granted the company Fast Track Designation for ReNetX Bio’s clinical therapy (AXER-204) for the potential treatment of Chronic Spinal Cord Injury (SCI).  ReNetX Bio is currently conducting a Phase 1/2 clinical trial “RESET” in patients with SCI, with topline results expected in 2021.