Class Action Filed Against PepGen Inc. by Pomerantz Law Firm Amidst Controversy

Overview of the Class Action Lawsuit

The Pomerantz Law Firm has recently filed a significant class action lawsuit against PepGen Inc. and specific officers, which has gained attention in the securities litigation landscape. The case was submitted to the United States District Court for the Eastern District of New York and is cataloged under case number 25-cv-03221. The lawsuit targets all individuals and entities, excluding the defendants, who purchased or acquired PepGen securities between March 7, 2024, and March 3, 2025. Plaintiffs seek recovery for damages that were allegedly caused by the company's breaches of federal securities laws.

Key Details of PepGen's Operations

Based in the clinical-stage biotechnology sphere, PepGen Inc. is primarily engaged in creating oligonucleotide therapeutics aimed at treating severe neuromuscular and neurological conditions. The company's most prominent candidate was PGN-EDO51, designed to tackle Duchenne muscular dystrophy (DMD), a genetic ailment that results in progressive muscle degeneration. PepGen’s goal with PGN-EDO51 was to develop a strategy for skipping exon 51 in the dystrophin transcript, addressing a significant therapeutic target for approximately 13% of DMD cases.

The Class Period and Allegations

Within the specified class period, the lawsuit asserts that the defendants, which include key company officials, made misleading statements regarding the clinical and regulatory viability of PGN-EDO51. Investors were allegedly led to believe in the drug's potential effectiveness and safety, which did not align with the underlying realities of clinical trial data.

The complaint cites four main points: 1) The efficacy and safety of PGN-EDO51 were misrepresented; 2) Deficiencies in the CONNECT2 study raised serious questions regarding the treatment's chances of receiving FDA approval; 3) Due to unresolved issues, it became highly probable that PepGen would cease the CONNECT2 study; and 4) Consequently, all public statements made by the defendants were materially false and misleading.

Clinical Trial Developments

During the class period, there were crucial developments related to PepGen's clinical trials. On July 30, 2024, PepGen announced "positive clinical data" from the initial dose cohort in their CONNECT1 study. However, analysts quickly critiqued this data as failing to meet the company's initial expectations. PepGen's stock responded dramatically to this news, plunging by over 32% shortly thereafter.

On December 16, 2024, the FDA issued a clinical hold regarding PepGen's IND application for the CONNECT2 study, indicating concerns about patient safety and study deficiencies, which further negatively affected the stock value.

In January 2025, PepGen acknowledged safety concerns in its CONNECT1 trial results and revealed further communication from Health Canada, requesting additional data on safety issues before continuation. Following these announcements, their stock faced a further decline of nearly 22%.

By March 2025, the firm decided to pause the CONNECT2 study amid ongoing reviews of the CONNECT1 data, and more bad news emerged in late May 2025 when a press release revealed that PGN-EDO51 failed to meet target dystrophin levels overall, leading to a discontinuation of its development.

Conclusion and Next Steps

The Pomerantz firm, renowned in the realms of corporate and securities litigation, has positioned itself as a powerful advocate for shareholder rights against alleged corporate misconduct. Investors of PepGen who acquired their shares during the identified class period have until August 8, 2025, to apply for the role of Lead Plaintiff in this class action. For those interested, more details can be found at the firm's dedicated website, and inquiries can be directly made to legal representatives to facilitate joining the lawsuit.

Through their long history, including billions recovered for victims of security fraud, Pomerantz continues to uphold the legacy of protecting investors and pursuing justice for those affected by corporate transgressions.