Core Viewpoint - A class action lawsuit has been initiated against REGENXBIO, Inc. for allegedly disseminating false and misleading statements regarding the efficacy and safety of its gene therapy product RGX-111 during the class period from February 9, 2022, to January 27, 2026 [1][4]. Company Overview - REGENXBIO, Inc. is a clinical-stage biotechnology company focused on developing gene therapies that deliver functional genes to cells with genetic defects [3]. Product Information - The company is developing RGX-111, a one-time gene therapy aimed at treating severe Mucopolysaccharidosis Type I (MPS I), also known as Hurler syndrome [3]. Legal Issues - The class action lawsuit claims that during the class period, the company concealed material adverse facts about the RGX-111 trial study, leading to investor losses [4]. - On January 28, 2026, REGENXBIO announced that the U.S. FDA placed a clinical hold on RGX-111 after an intraventricular CNS tumor was found in a participant during the Phase I/II study, resulting in a nearly 18% drop in the company's stock price [5].
Portnoy Law Firm Announces Class Action on Behalf of REGENXBIO, Inc. Investors