RGNX ALERT: Levi & Korsinsky Investigates REGENXBIO Inc. for Possible Securities Fraud Violations

Core Viewpoint - REGENXBIO Inc. is under investigation for potential violations of federal securities laws following the FDA's clinical holds on its RGX-111 and RGX-121 programs, which resulted in a significant decline in the company's share price by 30-35% [1]. Regulatory Compliance - SEC disclosure rules mandate that public companies must provide material information for informed investment decisions, with Form 8-K allowing disclosure of material events not covered by other items [2]. - Rule 10b-5 prohibits material misstatements and omissions in securities transactions, covering both false statements and the omission of necessary facts [2]. Earnings Call Insights - During the Q3 2025 earnings call, CEO Curran Simpson highlighted positive regulatory interactions, noting that the FDA completed inspections with no observations, which may have created an asymmetric presentation of the company's regulatory standing [3]. - The Q3 2025 earnings call did not address the RGX-111 program for MPS I, despite it being a material pipeline asset later subjected to the FDA clinical hold, raising concerns about the completeness of information provided to shareholders [4].