REGENXBIO Stockholders Urged to Recover Losses

Robbins LLP Investigates Allegations of Misleading Investors About Drug Candidate RGX-111

Published on Mar. 2, 2026

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Robbins LLP has filed a class action lawsuit on behalf of REGENXBIO, Inc. (NASDAQ: RGNX) stockholders who purchased or acquired the company's securities between February 9, 2022 and January 27, 2026. The lawsuit alleges that REGENXBIO misled investors about the viability of its drug candidate RGX-111, which was placed on clinical hold by the FDA due to safety concerns.

Why it matters

This case highlights the importance of transparency and accurate disclosures by publicly traded biotechnology companies, especially regarding the development and safety of their drug candidates. Investors who lost money due to REGENXBIO's alleged misconduct may be eligible to recover their losses through the class action lawsuit.

The details

According to the complaint, REGENXBIO repeatedly touted RGX-111 as a promising clinical-stage AAV therapeutic product candidate for the treatment of MPS I, even announcing that it had received Fast Track designation from the FDA. However, the lawsuit alleges that the defendants were aware of serious safety issues with RGX-111, including the potential for central nervous system neoplasms, but failed to disclose this information to investors. In November 2023, REGENXBIO abruptly decided to de-prioritize RGX-111 and seek "strategic alternatives" for the program. On January 28, 2026, the company announced that the FDA had placed a clinical hold on RGX-111 and a related product, RGX-121, due to safety concerns, causing the stock price to decline by 17.8% in a single day.

  • The class period is from February 9, 2022 to January 27, 2026.
  • On January 28, 2026, REGENXBIO announced the FDA had placed a clinical hold on RGX-111 and RGX-121.

The players

REGENXBIO, Inc.

A clinical-stage biotechnology company providing gene therapies that deliver functional genes to cells with genetic defects in the United States.

Robbins LLP

A recognized leader in shareholder rights litigation, dedicated to helping shareholders recover losses, improve corporate governance structures, and hold company executives accountable for their wrongdoing since 2002.

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What’s next

Shareholders who wish to serve as lead plaintiff for the class must submit their papers to the court by April 14, 2026.

The takeaway

This case highlights the importance of transparency and accurate disclosures by publicly traded biotechnology companies, especially regarding the development and safety of their drug candidates. Investors who lost money due to REGENXBIO's alleged misconduct may be eligible to recover their losses through the class action lawsuit.