#United States #New York #Pomerantz LLP #PepGen Inc #PGN-EDO51

Pomerantz Law Firm Files Class Action Against PepGen Inc.

On July 7, 2025, Pomerantz LLP announced the initiation of a class action lawsuit against PepGen Inc. (NASDAQ: PEPG) and certain of its executives. The lawsuit, filed in the United States District Court for the Eastern District of New York, is documented under case number 25-cv-03221. This action represents a collective effort on behalf of individuals and entities, excluding the defendants, who engaged in the purchase or acquisition of PepGen securities during the significant timeframe from March 7, 2024, to March 3, 2025 (the "Class Period"). The primary objective of this lawsuit is to recover damages stemming from alleged violations of federal securities laws by the defendants and to seek remedies under Sections 10(b) and 20(a) of the Securities Exchange Act of 1934, as well as Rule 10b-5 instituted under it.

Investors who bought or acquired PepGen securities during the Class Period have until August 8, 2025, to petition the Court for a position as Lead Plaintiff in the class action. Interested parties can obtain a copy of the Complaint at www.pomerantzlaw.com. For further discussions regarding this action, individuals can reach out to Danielle Peyton via email at [email protected] or by phone at 646-581-9980 (toll-free at 888.4-POMLAW, Ext. 7980). Individuals inquiring through email are encouraged to include their mailing address, contact number, and the total number of shares purchased.

Background on PepGen Inc.

PepGen is a biotechnology firm at the clinical stage, concentrating on the exploration of oligonucleotide therapeutics aimed at treating severe neuromuscular and neurological disorders. The company's lead product candidate, PGN-EDO51, is a uniquely formulated oligonucleotide peptide designed to target Duchenne muscular dystrophy (DMD), a genetic condition known for causing progressive muscle deterioration and weakness.

Duchenne muscular dystrophy results from a mutation in the dystrophin gene, which restricts the production of the dystrophin protein. This deficiency gives rise to several clinical symptoms associated with the condition. PepGen asserts that PGN-EDO51 was specifically developed to skip exon 51 of the dystrophin transcript—a known therapeutic target for approximately 13% of DMD patients—thereby promoting the synthesis of a reduced yet functional dystrophin protein.

Initially, PepGen was evaluating the efficacy of PGN-EDO51 in the treatment of DMD through two Phase 2 clinical trials named CONNECT1-EDO51 (denoted as "CONNECT1") and CONNECT2-EDO51 (denoted as "CONNECT2").

Throughout this time, the defendants continually highlighted PGN-EDO51's clinical, regulatory, and commercial potential, claiming that it could generate the dystrophin protein and detailing the prospects linked with the CONNECT1 and CONNECT2 studies.

Allegations in the Complaint

The allegations set forth in the complaint indicate that during the Class Period, the defendants engaged in making materially misleading statements concerning the company's operations, business, and future outlook. More specifically, the defendants purportedly:

1. Misrepresented the efficacy and safety of PGN-EDO51 compared to what they had indicated to investors.
2. Labeled the CONNECT2 study as potentially hazardous or lacking necessary requirements to gain U.S. Food and Drug Administration (FDA) approval.
3. Led investors to believe that PepGen was unlikely to withdraw from the CONNECT2 study, despite the misleading nature of previous statements.
4. Ultimately overstated PGN-EDO51's clinical, regulatory, and commercial prospects, while continuously providing false and misleading public statements.

On July 30, 2024, PepGen published a press release announcing seemingly promising clinical data from the first dose cohort (5 mg/kg) of PGN-EDO51 within its ongoing CONNECT1 study. They reported a mean absolute dystrophin level of 0.61% of normal, showcasing a 0.26% change from baseline after four doses by week 13 using Western blot analysis. However, this announcement was met with skepticism from analysts; for instance, a Stifel analyst commented that the observed increase in dystrophin was below expectations. Consequently, PepGen’s stock price decreased by $5.55, equating to a drop of 32.69%, ultimately closing at $11.43 per share on July 31, 2024.

Regulatory Challenges and Stock Volatility

The situation escalated on December 16, 2024, when PepGen revealed it received a notice from the FDA placing a clinical hold on its Investigational New Drug application meant to initiate the CONNECT2 clinical trial for DMD patients in the U.S. This hold indicated that the FDA had reservations concerning patient safety related to the CONNECT2 study or identified other deficiencies.

Following this announcement, PepGen's stock price dipped by $0.17 or 3.63% down to $4.51 per share. Further, as of January 29, 2025, PepGen admitted to safety issues flagged in the CONNECT1 study while acknowledging the FDA's concerns regarding the CONNECT2 study. This revelation led to an additional decline of $0.40 per share, marking a 21.74% decrease leading to a closing price of $1.44.

On March 4, 2025, PepGen announced a voluntary cessation of the CONNECT2 study, presenting another setback for investors as the stock dropped a further $0.53, settling at $2.28. Ultimately, on May 28, 2025, PepGen conceded that PGN-EDO51 did not achieve the desired dystrophin levels in the CONNECT1 study and opted to terminate its DMD programs altogether.

About Pomerantz LLP

Founded by the renowned legal pioneer Abraham L. Pomerantz, whose legacy remains influential in the field of corporate, securities, and antitrust class litigation, Pomerantz LLP has upheld its legacy for over 85 years. With offices spanning across New York, Chicago, Los Angeles, London, Paris, and Tel Aviv, the firm has championed the rights of victims of corporate misconduct, securities fraud, and breaches of fiduciary duty, recovering billions of dollars in damages for class members over the years.

In summary, the Pomerantz Law Firm's class action against PepGen Inc. and its executives embodies a significant episode within the landscape of securities law and corporate accountability. Investors affected during the defined Class Period are encouraged to unite and seek the justice that they rightfully deserve.