NEW YORK, June 10, 2025 (GLOBE NEWSWIRE) — Pomerantz LLP announces that a class action lawsuit has been filed against PepGen Inc. (“PepGen” or the “Company”) (NASDAQ: PEPG) and certain officers. The class action, filed in the United States District Court for the Eastern District of New York, and docketed under 25-cv-03221, is on behalf of a class consisting of all persons and entities other than Defendants that purchased or otherwise acquired PepGen securities between March 7, 2024 and March 3, 2025, both dates inclusive (the “Class Period”), seeking to recover damages caused by Defendants’ violations of the federal securities laws and to pursue remedies under Sections 10(b) and 20(a) of the Securities Exchange Act of 1934 and Rule 10b-5 promulgated thereunder, against the Company and certain of its top officials.
If you are an investor who purchased or otherwise acquired PepGen securities during the Class Period, you have until August 8, 2025 to ask the Court to appoint you as Lead Plaintiff for the class. A copy of the Complaint can be obtained at www.pomerantzlaw.com. To discuss this action, contact Danielle Peyton at newaction@pomlaw.com or 646-581-9980 (or 888.4-POMLAW), toll-free, Ext. 7980. Those who inquire by e-mail are encouraged to include their mailing address, telephone number, and the number of shares purchased.
[Click here for information about joining the class action]
PepGen is a clinical-stage biotechnology company that focuses on the development of oligonucleotide therapeutics for use in the treatment of severe neuromuscular and neurologic diseases. The Company’s lead product candidate was PGN-EDO51, a proprietary enhanced delivery oligonucleotide (“EDO”) peptide for the treatment of Duchenne muscular dystrophy (“DMD”), a genetic disorder characterized by progressive muscle degeneration and weakness.
DMD is caused by the mutation of the dystrophin gene, resulting in, inter alia, a limited production of the dystrophin protein, which in turn leads to DMD’s clinical features. According to PepGen, “PGN-EDO51 [wa]s designed to skip exon 51 of the dystrophin transcript, an established therapeutic target for approximately 13% of DMD patients, thereby . . . enabling the production of a truncated, yet functional dystrophin protein.”
PepGen had been evaluating PGN-EDO51 as a treatment for DMD in two Phase 2 clinical trials—the CONNECT1-EDO51 (“CONNECT1”) and CONNECT2-EDO51 (“CONNECT2”) studies.
At all relevant times, Defendants touted PGN-EDO51’s clinical, regulatory, and commercial prospects, including, inter alia, PGN-EDO51’s ability to produce the dystrophin protein and the design, prospects, and results of the CONNECT1 and CONNECT2 studies.
The complaint alleges that, throughout the Class Period, Defendants made materially false and misleading statements regarding the Company’s business, operations, and prospects. Specifically, Defendants made false and/or misleading statements and/or failed to disclose that: (i) PGN-EDO51 was less effective and safe than Defendants had led investors to believe; (ii) the CONNECT2 study was dangerous or otherwise deficient for purposes of U.S. Food and Drug Administration (“FDA”) approval; (iii) as a result of all the foregoing, PepGen was likely to halt the CONNECT2 study, and PGN-EDO51’s clinical, regulatory, and commercial prospects were overstated; and (iv) as a result, Defendants’ public statements were materially false and misleading at all relevant times.
On July 30, 2024, PepGen issued a press release announcing purported “positive clinical data from the first dose cohort (5 mg/kg) of PGN-EDO51” in its ongoing CONNECT1 study. Among other results, the Company reported that “PGN-EDO51 achieved a mean absolute dystrophin level of 0.61% of normal and a 0.26% change from baseline after 4 doses, measured at week 13 by Western blot analysis.” However, as subsequently noted by a Stifel analyst, “the magnitude of dystrophin increase was below what [PepGen] anticipated, which is disappointing[.]” Likewise, a Leerink Partners analyst noted that the low dose missed PepGen’s expectations of 1% or greater dystrophin expression.
On this news, PepGen’s stock price fell $5.55 per share, or 32.69%, to close at $11.43 per share on July 31, 2024.
On December 16, 2024, PepGen issued a press release announcing that it had received a clinical hold notice from the FDA regarding an Investigational New Drug (“IND”) application “to initiate the [CONNECT2] clinical trial in patients with [DMD]” in the U.S. Notably, the FDA’s issuance of a clinical hold notice for the IND application indicated that the FDA had concerns regarding risks posed to patients in the CONNECT2 study and/or there were other deficiencies associated with the study.
On this news, PepGen’s stock price fell $0.17 per share, or 3.63%, to close at $4.51 per share on December 16, 2024.
On January 29, 2025, PepGen issued a press release providing updates regarding safety concerns observed in the CONNECT1 study and the FDA’s concerns regarding the CONNECT2 study. With respect to the CONNECT1 study, the press release stated, inter alia, that “[d]osing of one of the[] . . . participants [in the 10 mg/kg cohort] was paused due to a reduction of his estimated glomerular filtration rate[.]” In addition, PepGen “ha[d] received communication from Health Canada . . . request[ing] additional information from the Company to address Health Canada’s safety concerns before any further dose escalation or enrollment of any additional participants at the current dose levels.” With respect to the CONNECT2 study, the same press release stated, in relevant part, that “[t]he Company is working with the FDA to address its questions regarding supportive data for the dosing levels planned for the patient population.”
Following these disclosures, PepGen’s stock price fell $0.40 per share, or 21.74%, to close at $1.44 per share on January 30, 2025.
On March 4, 2025, PepGen issued a press release “announc[ing] its voluntary decision to temporarily pause the [CONNECT2] study . . . until the Company can review results from the 10 mg/kg cohort in the ongoing [CONNECT1] study.”
On this news, PepGen’s stock price fell $0.53 per share, or 18.86%, to close at $2.28 per share on March 4, 2025.
Then, on May 28, 2025, PepGen issued a press release announcing that “PGN-EDO51 did not achieve target dystrophin levels” in the CONNECT1 study and had chosen to discontinue development of its DMD programs.
Pomerantz LLP, with offices in New York, Chicago, Los Angeles, London, Paris, and Tel Aviv, is acknowledged as one of the premier firms in the areas of corporate, securities, and antitrust class litigation. Founded by the late Abraham L. Pomerantz, known as the dean of the class action bar, Pomerantz pioneered the field of securities class actions. Today, more than 85 years later, Pomerantz continues in the tradition he established, fighting for the rights of the victims of securities fraud, breaches of fiduciary duty, and corporate misconduct. The Firm has recovered billions of dollars in damages awards on behalf of class members. See www.pomlaw.com.
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CONTACT:
Danielle Peyton
Pomerantz LLP
dpeyton@pomlaw.com
646-581-9980 ext. 7980
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