REGENXBIO($RGNX) Misleading Statements About RGX-111 Safety Case

• $RGNX investors filed a claim against REGENXBIO for allegedly misleading investors about the safety and viability of its RGX-111 gene therapy program (MPS I/Hurler syndrome).

• After the company disclosed that the FDA placed a clinical hold on RGX-111 following the discovery of an intraventricular CNS tumor in a treated trial participant, $RGNX fell 17.8% on January 27, 2026.

• $RGNX investors can join this case to be notified about potential recovery.

Case Details:

Between February 9, 2022 and January 27, 2026, REGENXBIO told investors that RGX-111 was progressing positively, emphasizing that the therapy was well-tolerated and repeatedly highlighting encouraging biomarker activity and neurodevelopmental data, including statements that the trial showed no drug-related serious adverse events. Executives reinforced this message through press releases and earnings call commentary describing RGX-111 as showing “promising” or “compelling” results and positioning it as an important program in the company’s pipeline.

However, during this period, investors allege that RGX-111 faced serious undisclosed safety risks, including the potential for CNS neoplasm (tumor) risk associated with the therapy. According to the complaint, REGENXBIO failed to disclose material safety concerns while continuing to present the program as safe and on track.

Then, on January 28, 2026, the company revealed that the FDA placed a clinical hold on RGX-111 after a routine brain MRI identified an intraventricular CNS tumor in an asymptomatic participant who had received RGX-111 years earlier, and preliminary analysis suggested an AAV vector genome integration event associated with proto-oncogene overexpression. Following this disclosure, the stock dropped 17.8%, closing at $11.01. Investors allege this news revealed the previously concealed risks and corrected the market’s understanding of RGX-111’s safety profile.

Based on these events, $RGNX investors filed a claim against REGENXBIO, alleging the company:

• It misrepresented and/or concealed material safety risks associated with RGX-111, including the risk of CNS tumors/neoplasms

• It misled investors by repeatedly emphasizing positive safety and tolerability statements (including “no drug-related serious adverse events”) while allegedly omitting known safety concerns

• It artificially inflated the stock price by portraying RGX-111 as safer and more viable than it allegedly was, causing investor losses when the truth emerged

Investors argue REGENXBIO misled the market about the safety risks and overall viability of RGX-111, causing losses when the clinical hold and tumor findings were disclosed.