REGENXBIO Faces Class Action Over Gene Therapy Safety Disclosures

GlobeNewswire Inc.GlobeNewswire Inc.
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Key Takeaway

REGENXBIO faces class action lawsuit over allegedly false safety disclosures for gene therapy RGX-111. FDA clinical hold triggered 17.8% stock drop after adverse trial findings.

REGENXBIO Faces Class Action Over Gene Therapy Safety Disclosures

The Gross Law Firm has filed a class action lawsuit against REGENXBIO Inc. (RGNX), seeking to represent shareholders who acquired shares during a nearly four-year period spanning February 9, 2022 through January 27, 2026. The complaint alleges that company officials made materially false and misleading representations regarding the safety and efficacy profile of RGX-111, an investigational gene therapy candidate developed to treat Hurler syndrome, while simultaneously withholding critical adverse information from the market.

The litigation was triggered by a significant catalyst on January 28, 2026, when the U.S. Food and Drug Administration imposed a clinical hold on RGX-111 development activities. The regulatory action followed the identification of an intraventricular central nervous system tumor in a clinical trial participant. The announcement precipitated a sharp equity decline, with REGENXBIO shares dropping 17.8 percent in a single trading session, closing at $11.01 compared to the prior close of $13.41.

The lawsuit represents one of several accountability mechanisms available to investors who sustained losses during the extended disclosure period. Shareholders meeting the class definition are being encouraged to contact legal counsel to understand their potential participation rights and recovery options through the litigation process.

Source: GlobeNewswire Inc.

Back to newsPublished Feb 18

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