A securities class action has been filed against REGENXBIO, Inc. (RGNX) on behalf of all investors who purchased or otherwise acquired REGENXBIO securities between February 9, 2022 through January 27, 2026. This case has been filed in the USDC – MD.
REGENXBIO provided investors with material information concerning REGENXBIO’s plan to develop and commercialize its product candidate RGX-111, a one-time gene therapy for the treatment of severe Mucopolysaccharidosis Type I, also known as Hurler syndrome. Defendants’ statements included, among other things, REGENXBIO’s positive assertions of RGX-111’s future trial success based on continuing positive biomarker and safety data from the ongoing PhaseI/II study. 3. Defendants provided these overwhelmingly positive statements to investors while, at the same time, disseminating false and misleading statements and/or concealing material adverse facts concerning the efficacy and safety of its RGX-111 trial study.
On January 28, 2026, REGENXBIO issued a press release announcing that the FDA placed a clinical hold on its investigational gene therapy RGX-111. Defendants announced that an intraventricular CNS tumor was found in a participant treated in its RGX-111 Phase I/II study. Following this news, the price of REGENXBIO’s common stock declined from a closing market price of $13.41 per share on January 27, 2026, REGENXBIO’s stock price fell to $11.01 per share on January 28, 2026, a decline of 17.8% in the span of just a single day.