Levi & Korsinsky Files Complaint Against REGENXBIO Over Losses

Lawsuit seeks to recover losses for investors after FDA places clinical hold on gene therapy drug

Published on Feb. 14, 2026

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Levi & Korsinsky, LLP has filed a class action lawsuit against REGENXBIO Inc. (NASDAQ: RGNX) on behalf of investors who purchased the company's securities between February 9, 2022 and January 27, 2026. The lawsuit alleges that REGENXBIO provided investors with misleading information about the efficacy and safety of its RGX-111 gene therapy product, which the FDA later placed on clinical hold after a participant developed an intraventricular CNS tumor.

Why it matters

This lawsuit highlights the risks investors face when companies provide overly optimistic information about their drug development pipelines. Investors rely on accurate disclosures to make informed decisions, and allegations of misleading statements can lead to significant stock price declines and losses. The outcome of this case could set an important precedent for how pharmaceutical companies communicate clinical trial data to the public.

The details

According to the complaint, REGENXBIO made positive assertions about the future success of its RGX-111 gene therapy based on ongoing positive biomarker and safety data, while allegedly concealing material adverse facts about the drug's efficacy and safety. On January 28, 2026, REGENXBIO announced that the FDA had placed a clinical hold on RGX-111 after a participant developed an intraventricular CNS tumor. This news caused REGENXBIO's stock price to fall 17.8% in a single day.

  • On January 28, 2026, REGENXBIO announced the FDA clinical hold on RGX-111.
  • Investors have until April 14, 2026 to request to be appointed as lead plaintiff in the lawsuit.

The players

Levi & Korsinsky, LLP

A law firm that has secured hundreds of millions of dollars for aggrieved shareholders and has a track record of winning high-stakes securities litigation cases.

REGENXBIO Inc.

A biotechnology company developing gene therapy products, including the RGX-111 drug that is the subject of the lawsuit.

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What they’re saying

“Our firm is committed to ensuring that investors receive full compensation for losses caused by corporate misrepresentations.”

— Joseph E. Levi, Partner, Levi & Korsinsky

What’s next

The judge will decide on April 14, 2026 whether to appoint a lead plaintiff in the lawsuit.

The takeaway

This case highlights the importance of pharmaceutical companies providing accurate and transparent information to investors about the status and risks of their drug development pipelines. Investors who suffered losses due to alleged misrepresentations may be able to recover those losses through this class action lawsuit.