#USA #New York #REGENXBIO #RGX-111 #Stephen Pakola

REGENXBIO's Dr. Stephen Pakola Faces Securities Class Action

In a recent legal development, Stephen Pakola, M.D., who serves as the Executive Vice President and Chief Medical Officer at REGENXBIO, has been named in a significant securities class action lawsuit. This lawsuit claims that Pakola, during his tenure, made false public assurances regarding the safety of the company's gene therapy product, RGX-111. The implications of these claims have resulted in substantial financial losses for investors, amounting to millions.

The Background of the Allegations

On March 12, 2026, news broke about this serious legal action where Dr. Pakola's role was scrutinized. He is alleged to have concealed important safety risks associated with RGX-111 from investors, which became apparent following the disclosure of adverse findings on January 28, 2026. On that date, shares of REGENXBIO plummeted by $2.40, representing a dramatic 17.8% drop, closing the day at $11.01.

The allegations against Dr. Pakola revolve around his consistent communications about RGX-111 from February 2022 through November 2023, during which he reportedly assured the market that the therapy was 'well-tolerated' and highlighted 'no drug-related serious adverse events.' These repeated assertions of safety and therapeutic efficacy span several press releases and earnings calls, painting a glowing picture of RGX-111's profile.

Key Claims by Dr. Pakola

The securities class action outlines a series of statements by Dr. Pakola, including:

• - On February 9, 2022: He announced there were 'no drug-related serious adverse events' noted in the Phase I/II trial, coupled with 'encouraging' neurodevelopmental data.
• - On February 28, 2023: During the Q4 2022 earnings call, he reiterated the message that RGX-111 was 'well-tolerated' and faced no serious adverse effects related to the drug.
• - On May 3, 2023: In the Q1 earnings call, Pakola remarked that RGX-111's safety profile was commendable with a promising CNS activity noted in 8 patients.
• - On November 8, 2023: He acknowledged a change in strategy regarding RGX-111, indicating that the company would be exploring 'strategic alternatives' for the treatment.

Dr. Pakola’s Liability

As the Chief Medical Officer, Dr. Pakola held significant authority over the clinical programs of REGENXBIO and had control over the content released to the public concerning RGX-111. The complaint argues that he had access to non-public information about potential safety risks, including concerning CNS-related complications. Despite this knowledge, Dr. Pakola continued to present a predominantly favorable outlook on the safety of the therapy.

The legal proceeding cites Section 20(a) of the Securities Exchange Act, which focuses on the liability of controlling persons. The lawsuit positions Dr. Pakola as someone deeply involved in managing the company’s clinical data and as being responsible for the veracity of the public claims made regarding RGX-111. As Joseph E. Levi, the attorney representing the plaintiffs, noted, "Individual officers who sign SEC certifications bear personal responsibility for the accuracy of corporate disclosures."

Moving Forward

Investors looking to recover losses resulting from the alleged misleading communications are urged to submit their claims promptly, as the lead plaintiff deadline for this case is set for April 14, 2026. The firm Levi & Korsinsky, known for its expertise in securities litigation, is handling this case and has successfully recovered significant amounts for investors in past actions.

In conclusion, with mounting scrutiny on executive accountability in the biotechnology sector, this case against Dr. Pakola serves as a critical reminder of the importance of transparency in clinical communications. As the lawsuit unfolds, it highlights the intricate balance between investor relations and the ethical responsibilities of corporate executives in safeguarding shareholder interests. Investors and stakeholders will undoubtedly watch closely as further developments in this case emerge.