PepGen Inc Stock Price, News & Analysis

PepGen (Nasdaq: PEPG), a clinical-stage biotechnology company focused on oligonucleotide therapies for neuromuscular diseases, has announced two strategic appointments to its Board of Directors. Lisa Wyman, current Chief Technical and Quality Officer at Scholar Rock, and Dr. Mitchell H. Finer, co-founder and Strategic Advisor for ElevateBio, join the board.

Wyman brings expertise in scaling manufacturing for clinical trials and regulatory navigation, having previously led technical operations at Generate:Biomedicines and Acceleron Pharma, where she contributed to the company's $11.5B acquisition by Merck. Dr. Finer brings 34+ years of genetic therapy experience, having led development of four approved therapies at bluebird bio and holding executive positions across multiple biotech companies.

These appointments aim to strengthen PepGen's board expertise as the company advances its mid-stage clinical trials and Enhanced Delivery Oligonucleotide platform development.

PepGen (Nasdaq: PEPG) announced its upcoming participation at the 2025 Muscular Dystrophy Association Clinical & Scientific Conference in Dallas, featuring two oral presentations and five posters. The presentations will showcase data from two significant clinical trials:

1. The CONNECT1-EDO51 Phase 2 study evaluating PGN-EDO51 for Duchenne muscular dystrophy (DMD)

2. The FREEDOM-DM1 Phase 1 study of PGN-EDODM1 for myotonic dystrophy type 1 (DM1)

The conference, scheduled for March 16-19, 2025, will include poster presentations on the Enhanced Delivery Oligonucleotide (EDO) Platform, nonclinical data for both drug candidates, and detailed information about both clinical trials. All presentations will be made available on PepGen's website after the conference.

PepGen (Nasdaq: PEPG), a clinical-stage biotechnology company focused on developing next-generation oligonucleotide therapies for severe neuromuscular and neurological diseases, has announced its participation in two upcoming investor conferences.

The company will be present at the Leerink Partners Global Healthcare Conference 2025 in Miami, FL, delivering a Fireside Chat on Tuesday, March 11, 2025, at 3:00 p.m. ET. Additionally, PepGen will participate in the Stifel 2025 Virtual CNS Forum with a Fireside Chat scheduled for Wednesday, March 19, 2025, at 8:00 a.m. ET.

Webcasts of both presentations will be accessible through PepGen's website investor section under 'Events & Presentations'. Replay recordings will remain available for 90 days after each presentation.

PepGen (NASDAQ: PEPG) announced a temporary pause of its Phase 2 CONNECT2-EDO51 study in patients with Duchenne muscular dystrophy (DMD). The company will focus on the ongoing CONNECT1-EDO51 study, with results from the 10 mg/kg cohort expected in Q3 2025.

The decision allows PepGen to gather additional safety data and assess PGN-EDO51's impact on dystrophin levels before potentially improving CONNECT2's design. The first two cohorts of CONNECT1 are fully enrolled, and no new safety issues have been reported since January 23, 2025.

The company will also continue advancing its FREEDOM studies in myotonic dystrophy type 1 with PGN-EDODM1, where recent Phase 1 FREEDOM-DM1 study showed encouraging initial clinical data.

PepGen (NASDAQ: PEPG) reported Q4 and full-year 2024 financial results, highlighting positive initial data from its FREEDOM-DM1 trial. The trial showed mean splicing correction of 12.3% and 29.1% in 5 and 10 mg/kg cohorts respectively.

Key financial metrics include: Cash position of $120.2 million as of December 31, 2024, expected to fund operations into 2026; Q4 net loss of $22.2 million ($0.68 per share); and full-year 2024 net loss of $90.0 million ($2.85 per share).

The company's CONNECT1-EDO51 10 mg/kg cohort is fully enrolled with results expected in Q3 2025, while the FREEDOM-DM1 15 mg/kg cohort is currently dosing with results anticipated in H2 2025. R&D expenses increased to $76.5 million in 2024 from $68.1 million in 2023.

PepGen (NASDAQ: PEPG) announced positive initial clinical data from its FREEDOM-DM1 Phase 1 trial testing PGN-EDODM1 in myotonic dystrophy type 1 (DM1) patients. The trial showed significant mean splicing correction of 29.1% at 10 mg/kg dose and 12.3% at 5 mg/kg dose, measured 28 days post-dosing.

The drug demonstrated a favorable safety profile with mostly mild or moderate adverse events. One treatment-related serious adverse event of abdominal pain occurred in the 10 mg/kg cohort, potentially influenced by prohibited off-label drug use.

A dose-dependent increase in muscle tissue concentrations was observed. The company expects to report results from the 15 mg/kg cohort in H2 2025 and from the FREEDOM2 5 mg/kg cohort in Q1 2026.

PepGen (Nasdaq: PEPG) provided updates on its CONNECT clinical program for PGN-EDO51 in Duchenne muscular dystrophy (DMD). The CONNECT1-EDO51 Phase 2 trial has fully enrolled its 10 mg/kg cohort (n=4) and continues dosing the 5 mg/kg cohort (n=3). Clinical data from the 10 mg/kg cohort is expected by year-end 2025.

Two participants in the 10 mg/kg cohort experienced asymptomatic hypomagnesemia, now resolved with supplementation. One participant's dosing was paused due to reduced eGFR, though subsequent testing showed normal glomerular filtration rate. Health Canada has allowed continued dosing at current levels but requests additional safety information before further dose escalation.

The CONNECT2-EDO51 Phase 2 trial, open in the UK, received a clinical hold notice from the FDA regarding its US initiation. The company is working with regulators to address safety concerns and dosing questions.

PepGen (Nasdaq: PEPG) announced that the FDA has placed a clinical hold on its IND application for the CONNECT2-EDO51 Phase 2 study of PGN-EDO51 in Duchenne muscular dystrophy (DMD) patients. The FDA will provide an official clinical hold letter within 30 days. CONNECT2 is designed as a multinational, double-blind placebo-controlled, multiple ascending dose, 25-week clinical trial and remains open in the United Kingdom.

Meanwhile, the company continues to advance its open-label CONNECT1-EDO51 multiple ascending dose study in Canada, with the 10 mg/kg cohort now fully enrolled. All four patients in this cohort have received at least one dose.

PepGen (Nasdaq: PEPG) announced an inducement grant to its newly appointed Senior Vice President of Clinical Development, Steve Han, MD, PhD, MMSc. The grant consists of a non-qualified stock option to purchase 95,000 shares at $4.40 per share, vesting over four years with 25% vesting after one year and the remainder monthly over three years. The grant was made under PepGen's 2024 Inducement Plan and approved by the Compensation Committee as a material inducement to employment in accordance with Nasdaq Listing Rule 5635(c)(4).