Regenxbio Faces Class Action Over RGX-111 Safety After 17.8% Decline
Investors who bought shares from February 9, 2022 to January 27, 2026 allege Regenxbio misled them on RGX-111 safety after de-prioritizing the therapy in November 2023. An FDA clinical hold on RGX-111 and RGX-121 following an intraventricular CNS tumor report led to a 17.8% stock drop.
1. Class Action Filed
A class action lawsuit was filed on behalf of investors who purchased Regenxbio shares from February 9, 2022 through January 27, 2026, alleging the company misrepresented key safety data for its RGX-111 gene therapy and harmed shareholders upon the program’s de-prioritization in November 2023.
2. Claims of Misleading Safety Data
The complaint asserts that Regenxbio touted positive interim safety, tolerability and biomarker results for RGX-111, but knowingly withheld serious risks including potential CNS neoplasm, undermining investor confidence and compliance with regulatory standards.
3. FDA Clinical Holds and Market Reaction
On January 28, 2026, the FDA placed clinical holds on RGX-111 and RGX-121 following a reported intraventricular CNS tumor in a trial participant, triggering a 17.8% one-day stock decline from $13.41 to $11.01.
4. Shareholder Remedies and Deadlines
Shareholders seeking lead plaintiff status must submit papers by April 14, 2026; eligible investors may participate in potential recovery without fees, while nonparticipants remain absent class members.