REGENXBIO, Inc. Stockholders Have Rights - Stockholders Who Lost Money Investing in RGNX Should Contact Robbins LLP for Information About Recovering Their Losses
MWN-AI** Summary
REGENXBIO, Inc. (NASDAQ: RGNX), a clinical-stage biotechnology company specializing in gene therapies, is currently facing legal scrutiny following a class action lawsuit filed by Robbins LLP. This action affects all investors who acquired RGNX securities from February 9, 2022, to January 27, 2026. The lawsuit centers around allegations that the company misled investors regarding the viability of its drug candidate, RGX-111, designed to treat MPS I using its proprietary NAV AAVP vector.
According to the complaint, the company consistently presented RGX-111 as a promising therapy, emphasizing its Fast Track designation granted by the FDA in 2018 and purported positive results from Phase I/II studies. However, the lawsuit claims that REGENXBIO was aware of significant safety concerns related to RGX-111, including risks of central nervous system tumors. In November 2023, the company allegedly decided to deprioritize RGX-111 and explore "strategic alternatives," raising questions about its prior assurances.
The situation escalated when, on January 28, 2026, the FDA placed a clinical hold on RGX-111 after identifying a case of neoplasm in a trial participant. Consequently, REGENXBIO's stock plummeted from $13.41 to $11.01 in a single day, marking a 17.8% drop.
Investors affected by this decline may be eligible to join the class action, with the option to become a lead plaintiff by submitting their papers by April 14, 2026. Robbins LLP, recognized for its shareholder rights litigation, operates on a contingency fee basis, ensuring no upfront costs for representation. Interested investors are encouraged to reach out to Robbins LLP for further information on this ongoing legal situation and potential recovery options.
MWN-AI** Analysis
Investors in REGENXBIO, Inc. (NASDAQ: RGNX) should proceed with caution following recent developments regarding the company's lead drug candidate, RGX-111. The biotechnology firm specializes in gene therapies but has faced significant setbacks that have resulted in a sharp decline in its stock price.
On January 28, 2026, REGENXBIO announced that the FDA placed a clinical hold on RGX-111 following the identification of a serious safety issue, specifically a neoplasm in a clinical trial participant. This news caused the stock to plummet by nearly 18% in a single trading day, signifying a loss of investor confidence. Additionally, the company's decision to de-prioritize RGX-111 and seek "strategic alternatives" raises questions about its future pipeline and overall strategic direction.
Investors who purchased RGNX stock during the period between February 9, 2022, and January 27, 2026, may be eligible to participate in a class-action lawsuit alleging that the company misled shareholders regarding the drug’s viability. Given the turmoil surrounding RGX-111, potential class action participants are advised to consult with Robbins LLP or legal counsel to explore the implications for their investment.
Looking ahead, potential shareholders should consider waiting for clearer data on the resolution of the FDA's clinical hold and subsequent updates on the company's strategic plans before entering or re-entering a position in REGENXBIO. The uncertainty surrounding the company's product pipeline makes it a high-risk investment at this juncture.
Investors are urged to stay informed on further developments regarding the litigation process and the company’s response to the FDA’s concerns. The complexity of the biotech sector necessitates a careful approach, weighing the potential for recovery against the inherent risks of investing in clinical-stage firms.
**MWN-AI Summary and Analysis is based on asking OpenAI to summarize and analyze this news release.
PR Newswire
SAN DIEGO, March 2, 2026 /PRNewswire/ -- Robbins LLP reminds stockholders that a class action was filed on behalf of all investors who purchased or otherwise acquired REGENXBIO, Inc. (NASDAQ: RGNX) securities between February 9, 2022 and January 27, 2026. REGENXBIO is a clinical-stage biotechnology company providing gene therapies that deliver functional genes to cells with genetic defects in the United States.
For more information, submit a form, email attorney Aaron Dumas, Jr., or give us a call at (800) 350-6003.
What is the Class Period? February 9, 2022 – January 27, 2026
What are the allegations? Robbins LLP is Investigating Allegations that REGENXBIO, Inc. (RGNX) Misled Investors Regarding the Viability of its Drug Candidate RGX-111
According to the complaint, defendants continually touted RGX-111 as one of its lead clinical-stage AAV therapeutic product candidate RGX-111 for the treatment of MPS I using its proprietary NAV AAVP vector. Further, defendants announced in 2018 that RGX-111 had been granted Fast Track designation by the FDA and repeatedly represented that the Phase I/II RGX-111 studies were reporting positive results consistently highlighting "positive interim safety, tolerability, and biomarker data." Plaintiff alleges that in truth, defendants were aware of the serious safety issues relating to the RGX-111 study including the potential for CNS neoplasm and in November 2023 abruptly decided to de-prioritize its second-most advanced clinical candidate, RGX-111, and seek "strategic alternatives" for the program.
The complaint continues that on January 28, 2026, defendants 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. Further, the FDA also placed a clinical hold on RGX-121 citing "the similarities in products, study populations, and shared risk between the clinical studies." On this news, the price of REGENXBIO's common stock declined from a closing market price of $13.41 per share on January 28, 2026 to $11.01 per share on January 28, 2026, a decline of 17.8% in the span of just a single day.
What can shareholders do now? You may be eligible to participate in the class action against REGENXBIO, Inc. Shareholders who wish to serve as lead plaintiff for the class must submit their papers to the court by April 14, 2026. The lead plaintiff is a representative party who acts on behalf of other class members in directing the litigation. You do not have to participate in the case to be eligible for a recovery. If you choose to take no action, you can remain an absent class member. For more information, click here.
All representation is on a contingency fee basis. Shareholders pay no fees or expenses.
About Robbins LLP: A recognized leader in shareholder rights litigation, the attorneys and staff of Robbins LLP have been dedicated to helping shareholders recover losses, improve corporate governance structures, and hold company executives accountable for their wrongdoing since 2002.
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SOURCE Robbins LLP
FAQ**
What specific safety issues were allegedly concealed by REGENXBIO Inc. (RGNX) regarding its drug candidate RGX-11and how did these impact investor confidence?
How did the FDA's clinical hold on RGX-111 and RGX-1affect the stock price of REGENXBIO Inc. (RGNX) on January 28, 2026, and what implications does this have for current shareholders?
What steps can stockholders of REGENXBIO Inc. (RGNX) take to participate in the ongoing class action lawsuit, and what are the deadlines they should be aware of?
How does Robbins LLP plan to assist REGENXBIO Inc. (RGNX) investors in recovering losses, and what are the potential outcomes of the class action litigation?
**MWN-AI FAQ is based on asking OpenAI questions about REGENXBIO Inc. (NASDAQ: RGNX).
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