REGENXBIO(US:RGNX) Businesswire·2026-02-16 19:12Core Viewpoint - A class action lawsuit has been filed against REGENXBIO, Inc. for allegedly misleading investors about the viability of its drug candidate RGX-111, which has faced significant safety concerns and regulatory scrutiny [1]. Group 1: Allegations and Legal Proceedings - The lawsuit claims that REGENXBIO misrepresented the safety and efficacy of RGX-111, a gene therapy for MPS I, despite knowing about serious safety issues, including the potential for CNS neoplasm [1]. - The FDA placed a clinical hold on RGX-111 after a participant developed an intraventricular CNS tumor during the Phase I trial, leading to a significant drop in the company's stock price from $13.41 to $11.01, a decline of 17.8% in one day [1]. - Shareholders are encouraged to participate in the class action, with a deadline for lead plaintiff submissions set for April 14, 2026 [1]. Group 2: Company Background - REGENXBIO, Inc. is a clinical-stage biotechnology company focused on gene therapies that deliver functional genes to cells with genetic defects in the United States [1].