The REGENXBIO Inc. class action lawsuit was filed on behalf of those who purchased or otherwise acquired REGENXBIO Inc. (“REGENXBIO”) (NASDAQ: RGNX) securities between February 9, 2022 and January 27, 2026, inclusive (the “Class Period”). Captioned Kuik v. REGENXBIO Inc., No. 26-cv-00611 (D. Md.) the REGENXBIO class action lawsuit alleges that REGENXBIO and/or certain of its officers and/or directors violated federal securities laws by making false or misleading statements and/or omitted to disclose material information.
If you lost money as a result of your REGENXBIO investment and want to find out more about this action and your rights, fill out the form on this page or contact attorney Jonathan Naji, Esq. of KTMC by calling (484) 270-1453 or via e-mail at info@ktmc.com.
CASE BACKGROUND:
REGENXBIO is a clinical-stage biotechnology company that provides gene therapies for the treatment of genetic defects. On February 9, 2022, REGENXBIO announced positive initial data in its ongoing Phase I/II trial of RGX-111, a one-time gene therapy for the treatment of severe Mucopolysaccharidosis Type I (MPS I), also known as Hurler syndrome.
COMPLAINT ALLEGATION SUMMARY:
The complaint alleges that, throughout the Class Period, Defendants made materially false and/or misleading statements, as well as failed to disclose material facts about the company’s business, operations, and prospects. Specifically, Defendants misrepresented and/or failed to disclose that: (1) Defendants were aware of serious safety issues concerning its RGX-111 study, including the potential for central nervous system neoplasm; and (2) as a result of the foregoing, Defendants’ statements about the company’s business, operations, and prospects were materially false and misleading and/or lacked a reasonable basis at all relevant times.
WHY DID REGENXBIO’S STOCK DROP?
Throughout the Class Period, REGENXBIO touted the RGX-111 trial as providing promising results as a future gene therapy with potential FDA approval as early as late 2025. However, on January 28, 2026, REGENXBIO announced that the FDA placed a clinical hold on RGX-111, following preliminary analysis of a single, severe potential adverse event in a participant from Phase I. On this news, the REGENXBIO common stock price declined 17.8% in a single day.
THE LEAD PLAINTIFF PROCESS:
The Private Securities Litigation Reform Act of 1995 permits any investor who purchased or acquired REGENXBIO securities during the Class Period to seek appointment as lead plaintiff in the REGENXBIO class action lawsuit. A lead plaintiff is a representative party that acts on behalf of other class members in directing the litigation. In order to be appointed lead plaintiff, the Court must determine that the class member’s claim is typical of the claims of other class members, and that the class member will adequately represent the class. Your ability to share in any recovery is not, however, affected by the decision whether or not to serve as a lead plaintiff. Filling out the online form above or communicating with any counsel is not necessary to participate or share in any recovery achieved in this case. Any member of the purported class may move the court to serve as a lead plaintiff through counsel of his/her choice, or may choose to do nothing and remain an inactive class member.
ABOUT KESSLER TOPAZ MELTZER & CHECK, LLP:
Kessler Topaz Meltzer & Check, LLP (KTMC) is a leading U.S. plaintiff-side law firm focused on securities-fraud class actions and global investor protection. The firm represents individual investors as well as institutions, such as major pension funds, asset managers, and international investors. KTMC has led some of the largest recoveries in securities litigation and has been recognized by peers and the legal media with numerous accolades, including The National Law Journal’s Plaintiff’s Hot List and Trailblazers in Plaintiffs' Law, BTI Consulting Group’s Honor Roll of Most Feared Law Firms, The Legal Intelligencer’s Class Action Firm of the Year, Lawdragon’s Leading Plaintiff Financial Lawyers, and Law360’s Titans of the Plaintiffs Bar. The firm operates globally with offices in Pennsylvania and California. KTMC has recovered over $25 billion for our clients and the classes they represent.