Pepgen INC 8-K filings

PepGen Inc. announced positive clinical trial updates for its PGN-EDODM1 drug candidate for Myotonic Dystrophy Type 1, including DSMB recommendation for dose escalation and a cash runway extending into late 2027.

PepGen Inc. provided an update on its investigational therapy PGN-EDODM1 for Myotonic Dystrophy Type 1, highlighting promising safety and efficacy data from its FREEDOM studies.

PepGen posted topline results from the lowest-dose 5 mg/kg Phase 2 FREEDOM2-DM1 cohort showing clean safety, modest mean splicing vs placebo but stronger effect excluding one outlier, vHOT improvement trends, and maintained guidance for 10 mg/kg data in 2H 2026 with cash runway into 2H 2027.

PepGen Inc. updated its corporate presentation, highlighting positive single-dose splicing correction data for PGN-EDODM1 in Myotonic Dystrophy Type 1 and outlining upcoming clinical milestones.

PepGen Inc. announced a partial clinical hold on its FREEDOM2-DM1 Phase 2 trial by the U.S. FDA, alongside its year-end 2025 financial results and positive Phase 1 data.

PepGen Inc. announced the appointment of Joseph Vittiglio, Esq., as its new Chief Business and Legal Officer, bringing over two decades of executive leadership experience.

PepGen Inc. announced positive third-quarter 2025 financial results and significant clinical progress for its lead DM1 candidate, PGN-EDODM1, extending its cash runway into the second half of 2027.

PepGen Inc. has repriced approximately two-thirds of its employee stock options to $4.53 per share, aiming to retain and motivate key personnel through a critical company stage.

PepGen Inc. updated its corporate presentation, highlighting positive Phase 1 data for PGN-EDODM1 in Myotonic Dystrophy Type 1 with unprecedented splicing correction and outlining upcoming Phase 2 milestones.

PepGen Inc. announced the pricing and full exercise of an option for its public offering, raising approximately $107.6 million in net proceeds to fund clinical trials and operations.

PepGen Inc. announced unprecedented 53.7% mean splicing correction in DM1 patients with PGN-EDODM1, marking a significant clinical advancement.

PepGen Inc. announced its second quarter 2025 financial results and significant progress in its PGN-EDODM1 clinical program for Myotonic Dystrophy Type 1, including completing dosing in the FREEDOM-DM1 trial's 15 mg/kg cohort and advancing to the FREEDOM2 multiple ascending dose study.

PepGen Inc. announced the successful election of three Class III directors and the ratification of KPMG LLP as its independent registered public accounting firm at its 2025 Annual Meeting of Stockholders.

PepGen Inc. announced the discontinuation of its Duchenne muscular dystrophy (DMD) program, PGN-EDO51, following insufficient dystrophin protein levels in its CONNECT1-EDO51 study, and will now prioritize its promising myotonic dystrophy type 1 (DM1) program, PGN-EDODM1.

PepGen reports positive clinical data for its DM1 program and provides a financial update for the first quarter of 2025, highlighting key milestones and upcoming data readouts.

PepGen Inc. expands its Board of Directors with the addition of Mitchell Finer, Ph.D., and Lisa Wyman, bringing extensive experience in life sciences and clinical development.

Michelle L. Mellion, MD, has resigned from her position as Chief Medical Officer of PepGen Inc., effective April 4, 2025.

PepGen Inc. announced a temporary pause of its Phase 2 CONNECT2-EDO51 study for Duchenne muscular dystrophy (DMD) to focus on the ongoing CONNECT1-EDO51 study and review upcoming data.

PepGen reports promising early data from its FREEDOM-DM1 trial, demonstrating significant splicing correction in patients with myotonic dystrophy type 1 (DM1) after a single dose of PGN-EDODM1.

PepGen Inc. announces updates on its CONNECT clinical program for PGN-EDO51 in Duchenne muscular dystrophy (DMD), including progress in CONNECT1 and challenges with FDA hold on CONNECT2.

PepGen has announced a clinical hold by the FDA on its Investigational New Drug application for the CONNECT2-EDO51 trial for Duchenne muscular dystrophy.

PepGen reported its Q3 2024 financial results and provided updates on its clinical programs, including expected data readouts for its DM1 and DMD trials.

PepGen will present clinical and preclinical data on its Duchenne muscular dystrophy and myotonic dystrophy type 1 programs at the 29th Annual Congress of the World Muscle Society.

PepGen Inc. announces the retirement of director Christopher Ashton, Ph.D., effective September 30, 2024, reducing the board size from seven to six members.

PepGen Inc. has announced the appointment of Paul Streck, M.D., MBA, as Executive Vice President, Head of Research & Development, effective immediately.

PepGen reported its Q2 2024 financial results, along with positive clinical trial updates for its Duchenne muscular dystrophy and myotonic dystrophy programs.

PepGen's PGN-EDO51 shows promising early results in a Phase 2 trial for Duchenne muscular dystrophy, demonstrating higher exon skipping and dystrophin production compared to other similar therapies.

PepGen Inc. has appointed Afsaneh Mohebbi, Ph.D., as SVP of Portfolio and Program Management and Dave Borah, CFA, as SVP of Investor Relations and Corporate Communications.

PepGen Inc. has amended its corporate charter to limit the liability of certain officers, following approval at the 2024 Annual Meeting of Stockholders.

PepGen Inc. has promoted Michelle Mellion, M.D., to Chief Medical Officer and Hayley Parker, Ph.D., to Senior Vice President, Global Regulatory Affairs, effective immediately.