RGNX's Inadequate Risk Disclosures Allegedly Cost Investors $2.40/Share: Levi & Korsinsky, LLP

Disclosure Under Scrutiny: Were REGENXBIO's Risk Warnings About AAV Gene Therapy Adequate?

NEW YORK--(BUSINESS WIRE)--Levi & Korsinsky, LLP examines the adequacy of REGENXBIO, Inc.'s (NASDAQ: RGNX) risk disclosures to investors during the period between February 9, 2022 and January 27, 2026. Find out if you qualify to recover losses from inadequate disclosures. You may also contact Joseph E. Levi, Esq. at jlevi@levikorsinsky.com or (212) 363-7500.

REGENXBIO shareholders lost $2.40 per share, a 17.8% single-day decline, after the FDA placed a clinical hold on RGX-111 following discovery of an intraventricular CNS tumor linked to AAV vector genome integration. The lead plaintiff deadline is April 14, 2026.

What the Company Disclosed

Throughout the Class Period, REGENXBIO's SEC filings and public statements characterized RGX-111 as "well-tolerated" with "no drug-related serious adverse events." The complaint challenges whether these characterizations were adequate given that AAV-based intracisternal gene therapy carries recognized risks of delayed genome integration and potential oncogenic effects. Specifically, the lawsuit contends that:

- REGENXBIO repeatedly stated RGX-111 showed "positive interim safety, tolerability, and biomarker data" without disclosing the specific oncogenic risks of AAV vector integration in CNS tissue
- The Company highlighted FDA Fast Track designation as a signal of regulatory confidence while allegedly withholding material safety concerns
- Press releases from February 2022 through January 2025 emphasized "no drug-related serious adverse events" as a blanket safety assurance
- Even after de-prioritizing RGX-111 in November 2023, the Company continued to describe its results as "very promising" in a January 2025 partnership announcement with Nippon Shinyaku

What the Complaint Alleges Was Missing

The securities action charges that REGENXBIO's disclosures omitted specific, known risks related to CNS neoplasm potential in AAV-treated patients. The complaint identifies the November 2023 decision to abruptly de-prioritize RGX-111 as evidence that the Company was aware of serious safety concerns it failed to communicate to investors. Rather than disclosing these concerns, the Company sought "strategic alternatives" without explaining the underlying safety rationale.

Why Generic Warnings May Not Protect

The complaint contends that boilerplate risk factor language about general clinical trial uncertainties cannot substitute for disclosure of specific, known problems already affecting a program. As pleaded, when the Company possessed information about the potential for AAV vector genome integration events associated with proto-oncogene overexpression, generic cautionary language about "risks inherent in clinical development" was insufficient.

Speak with an attorney about whether RGNX disclosures harmed your investment or call (212) 363-7500.

"Generic risk factor language cannot substitute for disclosing specific, known problems that are already affecting a company's operations. When a biotechnology company possesses information about oncogenic risks in a clinical program and continues to characterize that program's safety profile as positive, investors are denied the opportunity to make informed decisions." -- Joseph E. Levi, Esq.

LEAD PLAINTIFF DEADLINE: April 14, 2026

Act now to protect your rights as an RGNX shareholder or contact Joseph E. Levi, Esq. at (212) 363-7500.

Levi & Korsinsky, LLP, Top 50 securities litigation firm (ISS, seven consecutive years). Over 70 professionals. Hundreds of millions recovered for investors.

Levi & Korsinsky, LLP
Joseph E. Levi, Esq.
Ed Korsinsky, Esq.
33 Whitehall Street, 27th Floor
New York, NY 10004
jlevi@levikorsinsky.com
Tel: (212) 363-7500
Fax: (212) 363-7171