RGX-111 is an investigational one-time AAV9 gene therapy candidate for severe mucopolysaccharidosis type I (MPS I, Hurler syndrome). The program has been in Phase I/II clinical development and uses gene delivery of alpha-L-iduronidase. As of January 29, 2026, partner communications reported an FDA clinical hold on RGX-111.
A class action lawsuit was filed against REGENXBIO covering the period from February 9, 2022 to January 27, 2026, following FDA clinical holds on gene therapies RGX-111 and RGX-121 after a CNS tumor was discovered in a trial participant.
The provided source articles lack sufficient accessible factual content for synthesis. One article is inaccessible, another covers unrelated stock performance topics, and the third concerns a different company entirely.
The FDA placed clinical holds on Regenxbio's RGX-111 and RGX-121 gene therapies following a tumor case in an MPS I patient. The company's stock fell nearly 18% on the news.
