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LOS ANGELES, June 26, 2025 (GLOBE NEWSWIRE) -- The Portnoy Law Firm advises PepGen Inc. ("PepGen" or the "Company") (NASDAQ: PEPG) investors of a class action representing investors that bought securities between March 7, 2024 and March 3, 2025, inclusive (the "Class Period"). PepGen investors have until August 8, 2025 to file a lead plaintiff motion.
Investors are encouraged to contact attorney Lesley F. Portnoy, by phone 310-692-8883 or email: lesley@portnoylaw.com, to discuss their legal rights, or click here to join the case. The Portnoy Law Firm can provide a complimentary case evaluation and discuss investors’ options for pursuing claims to recover their losses.
CASE ALLEGATIONS: PepGen is a clinical-stage biotechnology company focused on developing oligonucleotide therapeutics to treat severe neuromuscular and neurologic diseases. Its lead product candidate, PGN-EDO51, is a proprietary enhanced delivery oligonucleotide (“EDO”) peptide targeting Duchenne muscular dystrophy (“DMD”).
According to the class action lawsuit, throughout the Class Period, defendants made false and/or misleading statements and/or failed to disclose material facts, including that:
(i) PGN-EDO51 was less safe and effective than represented;
(ii) the CONNECT2 clinical trial was unsafe or otherwise inadequate for securing U.S. Food and Drug Administration (“FDA”) approval; and
(iii) as a result, PepGen was likely to halt the CONNECT2 trial and had overstated PGN-EDO51’s clinical, regulatory, and commercial prospects.
The Complaint further alleges that on July 30, 2024, PepGen announced “positive clinical data” from the first dose cohort (5 mg/kg) of PGN-EDO51 in its ongoing CONNECT1 study, reporting a mean absolute dystrophin level of 0.61% of normal and a 0.26% change from baseline. However, a Stifel analyst noted that “the magnitude of dystrophin increase was below what [PepGen] anticipated,” calling the results disappointing. Following this news, PepGen’s stock price declined nearly 33%.
On December 16, 2024, PepGen disclosed it had received a clinical hold notice from the FDA regarding its Investigational New Drug (IND) application for the CONNECT2 study in DMD patients, citing concerns over patient risk or other deficiencies in the trial. The stock declined further in response.
Then, on January 29, 2025, PepGen announced that dosing in the CONNECT1 study was paused for a participant in the 10 mg/kg cohort due to reduced kidney function, and that Health Canada had requested additional safety data before allowing further dose escalation. Additionally, PepGen stated it was working with the FDA to address questions about dosing plans for the CONNECT2 study. This news prompted another stock decline of approximately 22%.
Finally, on March 4, 2025, PepGen announced a voluntary temporary pause of the CONNECT2 study to review data from the 10 mg/kg cohort in CONNECT1. On this news, PepGen’s stock fell nearly 19%, according to the Complaint.
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