Investigation into Regenxbio: Questions Arise Over Disclosure Completeness Prior to FDA Action

Core Viewpoint - Regenxbio Inc. is under investigation for potential discrepancies between the information provided to investors and the actual safety developments in its gene therapy clinical programs, particularly following the FDA's clinical holds on its RGX-111 and RGX-121 programs due to safety concerns [1][2]. Group 1: Company Developments - On January 28, 2026, Regenxbio disclosed that the FDA placed clinical holds on its RGX-111 and RGX-121 programs after a tumor was identified in a trial participant, leading to a 30-35% decline in the company's share price [2]. - During the Q3 2025 earnings call on November 6, 2025, CEO Curran Simpson highlighted positive regulatory interactions, noting that the FDA completed inspections of clinical sites and the manufacturing facility with no observations, which may have created an asymmetric presentation of the company's regulatory standing [4]. - The Q3 2025 earnings call transcript did not mention the RGX-111 program for MPS I, despite it being a significant pipeline asset that would later face the same FDA clinical hold, raising concerns about the completeness of information provided to shareholders [5]. Group 2: Regulatory and Legal Context - SEC disclosure rules require public companies to provide material information necessary for informed investment decisions, and Rule 10b-5 prohibits material misstatements and omissions in securities transactions [3].