Overview

A class action lawsuit has been filed against REGENXBIO Inc. (“REGENXBIO” or the “Company”) (NASDAQ : RGNX) and certain of the Company’s senior executive officers (collectively, “Defendants”) alleging violations of the federal securities laws. The REGENXBIO lawsuit is brought on behalf of all persons and entities who purchased or otherwise acquired REGENXBIO common stock between February 9, 2022, and January 27, 2026, inclusive (the “Class Period”). Investors have until April 14, 2026, to seek appointment as lead plaintiff of the REGENXBIO class action lawsuit.

REGENXBIO is a clinical-stage biotechnology company providing gene therapies that deliver functional genes to cells with genetic defects in the United States.

Throughout the Class Period, Defendants made positive statements regarding RGX-111, a one-time gene therapy for Hurler syndrome and one of the Company’s lead product candidates.  For example, Defendants touted RGX-111 as a potentially “transformational” treatment and highlighted positive Phase I/II trial data.  Defendants also stated the treatment was “well tolerated” and associated with “no drug-related serious adverse events.” However, in truth, the complaint alleges that Defendants were aware of serious safety issues relating to RGX-111, including the potential for central nervous system (“CNS”) neoplasm. In November 2023 Defendants abruptly decided to de-prioritize RGX-111 and seek “strategic alternatives” for the program.

The truth was revealed on January 28, 2026, when REGENXBIO issued a press release announcing that the U.S. Food and Drug Administration (“FDA”) placed a clinical hold on RGX-111. In pertinent part, Defendants announced that an intraventricular CNS tumor was found in a participant treated in its RGX-111 Phase I/II study. Further, the FDA also placed a clinical hold on RGX-121, citing “the similarities in products, study populations, and shared risk between the clinical studies.”

Investors and analysts reacted negatively to the news, with the Company’s stock price declining nearly 18% in the span of a single day, falling from $13.41 per share on January 27, 2026, to $11.01 per share on January 28, 2026.

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If you purchased or otherwise acquired REGENXBIO common stock between February 9, 2022, and January 27, 2026, and you wish to serve as lead plaintiff in this lawsuit, you are encouraged to submit your information to DiCello Levitt LLP via the form on this page. 

You can also contact DiCello Levitt attorneys Brian O’Mara and Hani Farah by calling (888) 287-9005 or at investors@dicellolevitt.com. 

The deadline to apply to the Court to serve as a lead plaintiff in the REGENXBIO class action lawsuit is April 14, 2026.