Shareholder Lawsuit Filed Against REGENXBIO, Inc. Over Gene Therapy Concerns

Robbins LLP informs investors of class action lawsuit alleging REGENXBIO misled about safety issues with lead drug candidate RGX-111.

Published on Feb. 17, 2026

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A class action lawsuit has been filed against REGENXBIO, Inc., a clinical-stage biotechnology company, on behalf of investors who purchased the company's securities between February 9, 2022 and January 27, 2026. The lawsuit alleges that REGENXBIO misled investors about the safety and viability of its lead drug candidate RGX-111, a gene therapy for the treatment of MPS I, by touting positive interim data while allegedly being aware of serious safety issues including the potential for central nervous system neoplasms.

Why it matters

REGENXBIO is a prominent gene therapy company, and the allegations of misleading investors about the safety of its lead drug candidate could significantly impact the company's reputation and future prospects if proven true. The case also highlights the importance of transparency and accurate disclosures in the biotechnology industry, where investor confidence is crucial for funding research and development.

The details

According to the complaint, REGENXBIO repeatedly touted RGX-111 as a promising clinical-stage gene therapy candidate, highlighting 'positive interim safety, tolerability, and biomarker data.' However, the lawsuit alleges that the company was aware of serious safety issues, including the potential for central nervous system neoplasms (brain tumors). 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 following a preliminary analysis that identified a single case of neoplasm in a participant. This news caused REGENXBIO's stock price to decline by 17.8% in a single day.

  • On February 9, 2022, the class period for the lawsuit began.
  • In 2018, REGENXBIO announced that RGX-111 had been granted Fast Track designation by the FDA.
  • In November 2023, REGENXBIO decided to de-prioritize RGX-111 and seek 'strategic alternatives' for the program.
  • On January 28, 2026, REGENXBIO announced the FDA had placed a clinical hold on RGX-111.
  • The class period for the lawsuit ended on January 27, 2026.

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 shareholder rights law firm that is representing investors in the class action lawsuit against REGENXBIO.

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What’s next

The lead plaintiff in the class action lawsuit must be selected by April 14, 2026. Shareholders who wish to participate in the lawsuit can submit their papers to the court by this deadline.

The takeaway

This case highlights the importance of transparency and accurate disclosures in the biotechnology industry, where investor confidence is crucial for funding research and development. The allegations against REGENXBIO could significantly impact the company's reputation and future prospects if proven true.