Levi & Korsinsky LLP

03/25/2026 | Press release | Distributed by Public on 03/25/2026 08:02

Hurler or Hype? REGENXBIO Accused of Misleading Investors on RGX-111

Regenxbio told investors it was on the brink of a breakthrough.

A one time gene therapy. Encouraging biomarker data. No serious safety issues.

It sounded like hope for families and a huge opportunity for shareholders.

Starting in February 2022, the company highlighted positive early results for RGX-111, calling it well tolerated with no drug related serious adverse events. In February2023, executives doubled down, pointing to strong biomarker activity and developmental progress. Even in January 2025, they described the treatment as very promising in a new partnership announcement.

But on January 28, 2026, everything changed.

The FDA slammed RGX-111 with a clinical hold after a brain tumor was identified in a child trial participant, with causality still under review. The stock fell about 18% in a single day.

Investors were stunned. Confidence shaken.

Now, more shareholders are joining the lawsuit.

Join the Lawsuit
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