New York, New York--(Newsfile Corp. - January 29, 2026) - Levi & Korsinsky notifies investors that it has commenced an investigation into REGENXBIO Inc. ("REGENXBIO Inc.") (NASDAQ: RGNX) concerning potential violations of the federal securities laws.

On January 28, 2026, Regenxbio disclosed via Form 8-K that the FDA placed clinical holds on its RGX-111 and RGX-121 programs following the identification of a tumor in a trial participant. The disclosure prompted a 30-35% decline in the company's share price.

SEC disclosure rules require public companies to provide investors with material information necessary to make informed investment decisions. Item 8.01 of Form 8-K permits companies to disclose material events not specifically covered by other items. Rule 10b-5 under the Securities Exchange Act of 1934 prohibits material misstatements and omissions in connection with securities transactions. The regulation encompasses not only affirmative false statements but also the omission of facts necessary to make other statements not misleading.

During the Q3 2025 earnings call on November 6, 2025, CEO Curran Simpson highlighted positive regulatory interactions, stating: "The FDA completed inspections of our clinical sites and in-house manufacturing facility with no observations, a rare and significant achievement." The emphasis on favorable inspection results without corresponding disclosure of safety concerns being evaluated by the agency created an asymmetric presentation of the company's regulatory standing.

Notably, the Q3 2025 earnings call transcript contains no discussion of the RGX-111 program for MPS I, despite this program being a material pipeline asset that would later be subject to the same FDA clinical hold. The absence of any update on this program during a quarterly investor communication raises questions about the completeness of the information provided to shareholders.

If you suffered a loss on your REGENXBIO Inc. securities and would like to explore a potential recovery under the federal securities laws, Learn More About the Investigation or contact Joseph E. Levi, Esq. via email at jlevi@levikorsinsky.com or call (212)363-7500 to speak to our team of experienced shareholder advocates.

WHY LEVI & KORSINSKY: Over the past 20 years, Levi & Korsinsky LLP has established itself as a nationally-recognized securities litigation firm that has secured hundreds of millions of dollars for aggrieved shareholders and built a track record of winning high-stakes cases. The firm has extensive expertise representing investors in complex securities litigation and a team of over 70 employees to serve our clients. For seven years in a row, Levi & Korsinsky has ranked in ISS Securities Class Action Services' Top 50 Report as one of the top securities litigation firms in the United States. Attorney Advertising. Prior results do not guarantee similar outcomes.

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Source: Levi & Korsinsky, LLP