Regenxbio, Inc. Class Action Lawsuit – RGNX

According to the complaint, defendants 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.