STEPHEN PAKOLA OVERSAW RGX-111 SAFETY CLAIMS THAT COST RGNX INVESTORS MILLIONS: SUEWALLST, LLP

NEW YORK, March 19, 2026 /PRNewswire/ -- Stephen Pakola, M.D., REGENXBIO's Executive Vice President and Chief Medical Officer, is named as an individual defendant in a securities class action alleging that his repeated public assurances about the safety of RGX-111 gene therapy concealed material risks from investors. When the truth emerged on January 28, 2026, RGNX shares fell $2.40 per share, a decline of 17.8%, closing at $11.01.

As Chief Medical Officer, Dr. Pakola served as the primary spokesperson for REGENXBIO's clinical programs, including RGX-111, a gene therapy for severe Mucopolysaccharidosis Type I (MPS I). The complaint identifies Dr. Pakola as the executive who repeatedly communicated trial results to investors and the public across multiple press releases and earnings calls between February 2022 and November 2023.

The action claims Dr. Pakola made a series of statements emphasizing that RGX-111 was "well-tolerated" with "no drug-related serious adverse events" and highlighting "encouraging CNS biomarker activity." These statements spanned multiple disclosure events:

- February 9, 2022: Announced "no drug-related serious adverse events" and "encouraging" biomarker and neurodevelopmental data from the Phase I/II trial

- February 28, 2023: Reiterated on the Q4 2022 earnings call that RGX-111 was "well tolerated, with no drug-related serious adverse events"

- May 3, 2023: Stated on the Q1 2023 earnings call that "RGX-111 was well tolerated in 8 patients" with an "encouraging CNS profile"

- November 8, 2023: Acknowledged de-prioritization of RGX-111, stating the company would seek "strategic alternatives"

As a senior officer with direct oversight of clinical programs, Dr. Pakola possessed the power and authority to control the contents of REGENXBIO's reports and press releases concerning RGX-111 trial data. The complaint contends he had access to non-public information about safety risks, including the potential for CNS neoplasm, yet continued to present an overwhelmingly positive picture of the therapy's safety profile.

The securities action asserts that Dr. Pakola is liable as a controlling person under Section 20(a) of the Securities Exchange Act. As pleaded, he participated directly in the operation and management of the company's clinical affairs and was able to control the content of public disclosures about RGX-111's safety and efficacy.

LEAD PLAINTIFF DEADLINE: April 14, 2026

Levi & Korsinsky, LLP, Top 50 securities litigation firm (ISS, seven consecutive years). Over 70 professionals. Hundreds of millions recovered for investors.

SOURCE SueWallSt.com