Skip to main content
News Archive

REGENXBIO Receives FDA Fast Track Designation for RGX-111 Gene Therapy for the Treatment of Mucopolysaccharidosis Type I | REGENXBIO Inc.

By June 18, 2018May 22nd, 2025No Comments

regenxbio-logo

REGENXBIO Inc. (Nasdaq: RGNX), a leading clinical-stage biotechnology company seeking to improve lives through the curative potential of gene therapy based on its proprietary NAV® Technology Platform, today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for RGX-111. RGX-111 is a novel, one-time investigational treatment for Mucopolysaccharidosis Type I (MPS I), that is designed to deliver the human iduronidase (IDUA) gene directly to the central nervous system (CNS) using the NAV AAV9 vector.

{iframe}https://regenxbio.gcs-web.com/news-releases/news-release-details/regenxbio-receives-fda-fast-track-designation-rgx-111-gene{/iframe}

Search

You have successfully subscribed to the newsletter

There was an error while trying to send your request. Please try again.

BioHealth Innovation will use the information you provide on this form to be in touch with you and to provide updates and marketing.