REGENXBIO Inc. (NASDAQ: RGNX) is the subject of a class action lawsuit alleging securities law violations related to its disclosure practices surrounding the RGX-111 product candidate. According to the complaint, the company made statements regarding RGX-111's safety and efficacy profile while allegedly withholding material adverse information from investors. The allegations come following the FDA's decision to place a clinical hold on the program.
The clinical hold was issued after a clinical trial participant developed a tumor during the study. This development represents a significant setback for the gene therapy candidate and prompted the regulatory action. The timing between the adverse event and public disclosure of the regulatory hold forms the basis of the securities litigation.
The class action provides shareholders who purchased REGENXBIO securities during the relevant period an opportunity to seek recovery. Shareholders with questions about their legal rights regarding the matter are being directed to contact legal counsel specializing in securities claims.