A securities class action lawsuit has been filed against REGENXBIO Inc. (NASDAQ: RGNX) by Gainey McKenna & Egleston, alleging the company made misleading public statements regarding its RGX-111 gene therapy clinical trial while failing to adequately disclose emerging safety concerns to investors. The legal action follows the FDA's decision to impose a clinical hold on the investigational treatment after an intraventricular central nervous system tumor was identified in a trial participant.
The regulatory action marked a significant setback for REGENXBIO's therapeutic pipeline. The company's stock experienced a sharp decline of 17.8% on January 28, 2026, the trading day following the FDA's clinical hold announcement, reflecting investor concerns about the program's viability and the adequacy of prior disclosures regarding trial safety data.
The lawsuit represents an effort to hold the biopharmaceutical company accountable for its communications to shareholders during the period when adverse trial events were occurring. Class action litigation of this nature typically seeks to recover damages for investors who purchased REGENXBIO securities during the alleged period of misleading statements.