Kehoe Law Firm, P.C. is investigating potential securities fraud claims on behalf of investors of REGENEXBIO Inc. (“REGENEXBIO” or the “Company”) (NASDAQ: RGNX).
On February 9, 2026, REGENXBIO “. . . announced that it received a Complete Response Letter (‘CRL’) from the U.S. Food and Drug Administration . . . regarding the Company’s Biologics License Application (‘BLA’) for RGX-121, the Company’s investigational gene therapy for Mucopolysaccharidosis type II.”
The Company also reported that “[t]hroughout active discussions during the BLA process, REGENXBIO believed it had addressed the points raised in the CRL through the submission of additional data and responses to numerous information requests. Independent, leading global MPS and biomarker experts conducted analyses and reviews with the FDA, as well. Ultimately, the FDA did not agree the data set provided substantial evidence of effectiveness to support approval of RGX-121 for the treatment of MPS II.”
On this news, REGENEXBIO’s stock price was down more than 13% during intraday trading on February 10, 2026.
REGENEXBIO Investors May Have Legal Claims
REGENEXBIO investors with financial losses are encouraged to complete Kehoe Law Firm’s Stockholder Information Request Form or contact either John Kehoe, Esq., (215) 792-6676, Ext. 801, [email protected], or Michael Yarnoff, Esq., (215) 792-6676, Ext. 804, [email protected], [email protected], to learn more about the investigation and receive a free, no-obligation evaluation of potential legal claims.
About Kehoe Law Firm, P.C.
Kehoe Law Firm, P.C. is a nationally recognized, plaintiff-side class action firm dedicated to protecting investors and consumers from fraud and misconduct. Our attorneys have served as Lead or Co-Lead Counsel in major securities cases, recovering over $10 billion for institutional and individual investors.
Our firm litigates securities fraud, fiduciary breaches, unfair mergers and acquisitions, and antitrust violations, while also representing whistleblowers and advocating for victims of data breaches, consumer fraud, vehicle and product defects, employment law violations, retirement plan mismanagement, and other corporate and business misconduct. With a results-driven approach, we pursue justice and substantial recoveries for those we represent.
Kehoe Law Firm’s class action legal services are provided on a contingency-fee basis, meaning clients are not responsible for any fees or litigation expenses.
SEND US A MESSAGE
Contact Us
ADDRESS
Kehoe Law Firm, P.C.
2001 Market Street
Suite 2500
Philadelphia, PA 19103