A securities class action lawsuit has been initiated against REGENXBIO Inc., alleging the company made false and misleading statements regarding the efficacy and safety profile of its RGX-111 gene therapy candidate. The legal action follows the FDA's decision to place a clinical hold on both RGX-111 and RGX-121 programs after a trial participant developed a central nervous system tumor, prompting significant investor losses.
The FDA clinical hold announcement triggered a sharp market reaction, with REGENXBIO shares declining 17.9% on January 28, 2026. The development raised questions about the company's prior disclosures concerning the safety and therapeutic potential of the gene therapy programs, which had been a focal point of investor interest prior to the clinical hold.
Investors who suffered losses in REGENXBIO securities have until April 14, 2026 to petition the court for lead plaintiff status in the class action. Legal counsel is currently soliciting eligible shareholders to participate in the litigation process as the case proceeds.