PGN-EDO51

SAN DIEGO, June 12, 2025 /PRNewswire/ -- Robbins LLP reminds stockholders that a class action was filed on behalf of investors who purchased or otherwise acquired PepGen Inc. (NASDAQ:PEPG) securities between March 7, 2024 and March 3, 2025. 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"). For more information, submit a form, email attorney Aaron Dumas, Jr., or give us a call at (800) 350-6003. The Allegations: Robbins LLP is Investigating Allegations that PepGen Inc. (PEPG) Misled Investors Regarding the Viability of its Drug Candidate According to the complaint, defendants 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. The complaint alleges that 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." On this news, PepGen's stock price fell $0.40 per share, or 21.74%, to close at $1.44 per share on January 30, 2025. Then, 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. What Now: You may be eligible to participate in the class action against PepGen Inc. Shareholders who want to serve as lead plaintiff for the class must file a motion for lead plaintiff by August 8, 2025. The lead plaintiff is a representative party who acts on behalf of other class members in directing the litigation. You do not have to participate in the case to be eligible for a recovery. If you choose to take no action, you can remain an absent class member. For more information, click here. All representation is on a contingency fee basis. Shareholders pay no fees or expenses. About Robbins LLP: A recognized leader in shareholder rights litigation, the attorneys and staff of Robbins LLP have been dedicated to helping shareholders recover losses, improve corporate governance structures, and hold company executives accountable for their wrongdoing since 2002. To be notified if a class action against PepGen Inc. settles or to receive free alerts when corporate executives engage in wrongdoing, sign up for Stock Watch today. Attorney Advertising. Past results do not guarantee a similar outcome. SOURCE Robbins LLP WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

PepGen will prioritize its candidate for myotonic dystrophy 1, PGN-EDODM1, which is currently in a pair of trials.\n Months after causing safety concerns that led the FDA to hit a related trial with a clinical hold, a phase 2 trial of PepGen’s lead Duchenne muscular dystrophy (DMD) candidate has resulted in limited evidence for any clinical benefit, prompting the Boston biotech to scrap the asset and end all DMD R&D activities.In the phase 2 Connect1-EDO51 study,  PepGen’s exon 51-skipping oligonucleotide PGN-EDO51 only increased dystrophin levels to 0.59% of normal levels in four patients in the 10-mg/kg cohort, PepGen announced in a May 28 release.“Unfortunately, we believe that the amount of dystrophin produced by people in the trial is not enough to provide meaningful benefit to people with DMD,” PepGen said in a May 28 community letter (PDF). “We do not believe we can dose at a high enough level to produce an amount of dystrophin that would provide genuine benefit to people with DMD.”PepGen will stop dosing all patients enrolled in Connect1, the company said in the letter. The biotech will instead prioritize its candidate for myotonic dystrophy 1 (DM1), PGN-EDODM1, according to the release. PGN-EDODM1 is currently in a pair of trials, one phase 1 and the other phase 2. Connect1 in total enrolled seven boys between the ages of 6 and 16. After a 45-day screening period, patients received multiple ascending doses of PGN-EDO51 every four weeks for 16 weeks up to either 5 mg/kg or 10 mg/kg. Patients that completed the ascending doses then entered a long-term extension period that was meant to last 108 weeks, until around April 2027.PGN-EDO51 first caused trouble last December, when two patients in Connect1’s 10-mg/kg cohort developed asymptomatic magnesium deficiency. This prompted the FDA to put a second trial of the asset, Connect2, on hold, with PepGen later voluntarily pausing the U.K. arm of Connect2 in March 2025.Along with PGN-EDO51, PepGen’s DMD pipeline—now set to run dry—included three other assets, according to a snapshot of the company’s website archived June 22, 2024.PepGen’s DM1 program, now the biotech’s primary focus, also has a bumpy history. The phase 1 Freedom-DM1 trial was itself hit with a five-month FDA hold in 2023, seemingly due to issues with dosing.