Regenxbio Inc. (NASDAQ:RGNX) stock is trading lower on Monday after a regulatory update on its investigational gene therapy, RGX-121 (clemidsogene lanparvovec or Navsunli), for Mucopolysaccharidosis type II (MPS II), also known as Hunter Syndrome.
FDA Places Clinical Hold On RGX-121
The U.S. Food and Drug Administration (FDA) placed a clinical hold on RGX-121 following the discovery of asymptomatic spine MRI findings in five participants in the CAMPSIITE study.
The company said it does not expect to resubmit the RGX-121 Biologics License Application (BLA) in the near term.
Five Participants Show Asymptomatic Spine MRI Findings
