Core 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] Summary by Sections Allegations - 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 company had previously announced positive results from Phase I/II studies and received Fast Track designation from the FDA in 2018 [1] - In November 2023, REGENXBIO decided to deprioritize RGX-111 and seek strategic alternatives for the program [1] Regulatory Actions - On January 28, 2026, the FDA placed a clinical hold on RGX-111 due to a case of intraventricular CNS tumor in a trial participant [1] - The FDA also placed a clinical hold on RGX-121, citing similarities in products and shared risks between the studies [1] Market Impact - Following the announcement of the FDA's clinical hold, REGENXBIO's stock price fell from $13.41 to $11.01 per share, representing a decline of 17.8% in one day [1] Class Action Participation - Shareholders interested in participating in the class action must submit their papers by April 14, 2026, to serve as lead plaintiff [1] - Participation in the case is not required to be eligible for recovery, and all representation is on a contingency fee basis [1]
RGNX Stockholder Alert: Robbins LLP Remind Investors of the Class Action Lawsuit Against REGENXBIO, Inc.