Regenxbio falls after FDA rejects rare disease therapy

Regenxbio

09/02/2026 22:39

** Shares of drug developer Regenxbio RGNX.O fall 19.4% to $8.31 after hours

** Co says US FDA declined to approve its gene therapy RGX-121 for the treatment of a rare neurodegenerative disease called Hunter syndrome

** Co says FDA outlined several reasons for not approving the gene therapy, including uncertainty regarding the study eligibility criteria

     ** Co plans to work with FDA on a path forward to resubmit the marketing application

** RGNX gained 86.3% in 2025

(Reporting by Sneha S K)

((Sneha.SK@thomsonreuters.com))