Investors who lost money with shares of PepGen Inc. (NASDAQ: PEPG) should contact the Shareholders Foundation in connection with the Lawsuit

An investor, who purchased shares of PepGen Inc. (NASDAQ: PEPG), filed a lawsuit over alleged violations of Federal Securities Laws by PepGen Inc. in connection with certain allegedly false and misleading statements.

Investors who purchased shares of PepGen Inc. (NASDAQ: PEPG) have certain options and for certain investors are short and strict deadlines running. Deadline: August 8, 2025. NASDAQ: PEPG investors should contact the Shareholders Foundation at mail@shareholdersfoundation.com or call +1(858) 779 - 1554.

Boston, MA based PepGen Inc., a clinical-stage biotechnology company, 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.

On July 30, 2024, PepGen Inc. announced "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 December 16, 2024, PepGen Inc. announced that it had received a clinical hold notice from the FDAregarding 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 January 29, 2025, PepGen Inc. provided 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."

On March 4, 2025, PepGen Inc. 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."
Shares of PepGen Inc. (NASDAQ: PEPG) declined from $19.30 per share on July 29, 2024, to $1.15 per share on May 09, 2025.

Then, on May 28, 2025, PepGen Inc. announced that "PGN-EDO51 did not achieve target dystrophin levels" in the CONNECT1 study and had chosen to discontinue development of its DMD programs.

The plaintiff claims that between March 7, 2024 and March 3, 2025, the defendants made false and/or misleading statements and/or failed to disclose that PGN-EDO51 was less effective and safe than Defendants had led investors to believe, that the CONNECT2 study was dangerous or otherwise deficient for purposes of U.S. Food and Drug Administration ("FDA") approval, that 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 that as a result, Defendants' public statements were materially false and misleading at all relevant times.

Those who purchased shares of PepGen Inc. (NASDAQ: PEPG) have certain options and should contact the Shareholders Foundation.

Contact:
Michael Daniels
Shareholders Foundation, Inc.
3111 Camino Del Rio North
Suite 423
San Diego, CA 92108
Tel: +1-(858)-779-1554
E-Mail: mail@shareholdersfoundation.com

About Shareholders Foundation, Inc.
The Shareholders Foundation, Inc. is a professional portfolio monitoring and settlement claim filing service, and an investor advocacy group, which does research related to shareholder issues and informs investors of securities lawsuits, settlements, judgments, and other legal related news to the stock/financial market. Shareholders Foundation, Inc. is in contact with a large number of shareholders and offers help, support, and assistance for every shareholder. The Shareholders Foundation, Inc. is not a law firm. Referenced cases, investigations, and/or settlements are not filed/initiated/reached and/or are not related to Shareholders Foundation. The information is provided as a public service. It is not intended as legal advice and should not be relied upon.

This release was published on openPR.