Shareholders Sue RGNX Over Gene Therapy Study Claims

A class action lawsuit was filed against REGENEXBIO RGNX -5.88% ▼ on February 13, 2026.

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The federal securities class action alleges that plaintiffs acquired REGENEXBIO stock at artificially inflated prices between February 9, 2022 and January 27, 2026, known as the “Class Period.” Plaintiffs are now seeking compensation for financial losses incurred upon public revelation of the company’s alleged misconduct during that time. To learn whether you may be eligible for a recovery under this securities lawsuit, click here.

What Does RGNX Do?

• RGNX is a biotechnology company “on a mission to improve lives through the curative potential of gene therapy.”

• Founded in 2009, REGENEXBIO has focused its efforts on promoting a late-stage pipeline of single dose treatments for rare and retinal diseases. Specifically, the company says that it has promoted such treatments for conditions including, but not limited to, Mucopolysaccharidosis Type I (“MPS I” or “Hurler Syndrome”), Mucopolysaccharidosis Type II (“MPS II”),  wet AMD, and diabetic retinopathy.

• The company also claims that  thousands of patients have been treated with its AAV platform and that its investigational gene therapies can potentially “change the way healthcare is delivered for millions of people.”

Why are Investors Suing RGNX?

The company and three of its current and/or former senior officers (the “Individual Defendants”) are now accused of deceiving investors by lying or withholding important information about REGENEXBIO’s business and prospects during the Class Period.

In particular, they are accused of omitting truthful information about the safety of the RGX-111 study and other matters, from SEC filings and related material. By knowingly or recklessly doing so, they allegedly caused REGENEXBIO stock to trade at artificially inflated prices during the time in question. The truth came out on January 28, 2026.

That’s when the company announced that “the FDA placed a clinical hold on its investigational gene therapy RGX-111 following preliminary analysis of a single case of neoplasm (intraventricular CNS tumor) in a participant treated in its Phase I.” In this context, REGENEXBIO  shared that the FDA also placed a clinical hold on RGX-121 citing “the similarities in products, study populations, and shared risk between the clinical studies.”

Taking a Closer Look

As alleged,  REGENEXBIO and/or the Individual Defendants repeatedly made false and misleading public statements throughout the Class Period.

In a press release issued at the beginning of the Class Period, for instance, REGENEXBIO’s Chief Medical Officer, an Individual Defendant, stated in pertinent part: “This marks our first data presentation from the Phase I/II trial evaluating RGX-111 as a potential one-time gene therapy delivered directly to the central nervous system (CNS) for the treatment of severe MPS I. We are encouraged to see that RGX-111 has been well-tolerated with emerging evidence of CNS biomarker activity and improvements in neurodevelopmental function, which suggest biological activity in the CNS following one-time administration of RGX-111.”

Next, in a February 24, 2023 press release, the company stated in pertinent part: “As of January 17, 2023, RGX-111 was reported to be well tolerated in the eight patients enrolled in the Phase I/II clinical trial with no drug-related serious adverse events (SAEs).”

Lastly, in the same press release, the company’s then-CEO, an Individual Defendant, stated in relevant part: “RGX-111 is our second-most advanced clinical candidate in our neurodegenerative disease pipeline and is part of our ‘5x’25’ strategy to have five gene therapies either on the market or in late-stage development by 2025. We are encouraged to see that this potential one-time gene therapy using our NAV AAV9 vector continues to demonstrate compelling evidence of CNS biomarker activity.”

Actions You May Take

If you have purchased the Company’s stock during the Class Period, you may join the class action as a lead plaintiff, remain a passive class member, or opt out of this litigation and pursue individual claims that may not be available to the class as a whole. To learn more about your options, click here.

The deadline to file for lead plaintiff in this class action is April 14, 2026

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