Welcome to our dedicated page for PepGen news (Ticker: PEPG), a resource for investors and traders seeking the latest updates and insights on PepGen stock.
PepGen Inc. (Nasdaq: PEPG) is a clinical-stage biotechnology company developing next-generation oligonucleotide therapies for severe neuromuscular and neurological diseases. News about PEPG often centers on progress with its Enhanced Delivery Oligonucleotide (EDO) platform and its lead investigational candidate, PGN-EDODM1, in myotonic dystrophy type 1 (DM1).
Investors following PepGen’s news can expect updates on clinical trial milestones from the FREEDOM-DM1 Phase 1 single ascending dose study and the FREEDOM2-DM1 Phase 2 multiple ascending dose trial, including reported splicing correction data, safety observations, and study enrollment status. The company has highlighted results such as mean splicing correction in DM1 patients and described PGN-EDODM1 as generally well tolerated at evaluated doses in its communications.
PepGen’s news flow also includes corporate and financing announcements, such as underwritten public offerings of common stock under a shelf registration statement on Form S-3, with stated use of proceeds to fund the FREEDOM-DM1 and FREEDOM2-DM1 trials and general corporate purposes. Regulatory and intellectual property developments, including the issuance of a U.S. composition of matter patent for PGN-EDODM1 and FDA Orphan Drug and Fast Track designations for DM1, are additional themes in the company’s press releases.
Other PEPG news items feature executive and governance updates, such as the appointment of a Chief Business and Legal Officer and option repricing actions under the company’s equity plans, as well as participation in investor and scientific conferences where PepGen’s data are presented. For readers tracking PEPG stock, this news page provides a centralized view of clinical, regulatory, financial, and corporate developments that shape the company’s clinical-stage pipeline and capital strategy.
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).
PepGen Inc. (PEPG) reported Q3 2024 financial results with a net loss of $21.4 million ($0.66 per share), compared to $23.3 million ($0.98 per share) in Q3 2023. The company ended the quarter with $138.9 million in cash and equivalents, expected to fund operations into 2026. R&D expenses decreased to $17.7 million from $20.5 million year-over-year, while G&A expenses increased to $5.4 million from $4.2 million.
The company expects to report data from the FREEDOM-DM1 trial's 5 and 10 mg/kg cohorts in Q1 2025, and from the CONNECT1-EDO51 10 mg/kg cohort by end-2025. PepGen strengthened its leadership by appointing Paul Streck as Head of R&D.
PepGen (Nasdaq: PEPG), a clinical-stage biotechnology company focused on developing oligonucleotide therapies for severe neuromuscular and neurological diseases, has announced its participation in two upcoming investor conferences. The company will present at Guggenheim's Inaugural Healthcare Innovation Conference in Boston on November 11, 2024, at 1:00 p.m. ET, and at the Stifel 2024 Healthcare Conference in New York on November 19, 2024, at 11:30 a.m. ET. Both presentations will be available via webcast on PepGen's website, with replays accessible for 90 days afterward.
PepGen Inc. (Nasdaq: PEPG) announced its participation in the 29th Annual Congress of the World Muscle Society (WMS) in Prague, Czech Republic, from October 8-12, 2024. The company will present a short oral presentation and five posters on their Duchenne muscular dystrophy (DMD) and myotonic dystrophy type 1 (DM1) programs.
CEO James McArthur highlighted the favorable emerging safety profile of PGN-EDO51 in the CONNECT1-EDO51 trial, with no serious adverse events reported. The presentations will cover clinical and preclinical data on PGN-EDO51 for DMD and PGN-EDODM1 for DM1. Chief Medical Officer Michelle Mellion and Director of Research & Preclinical Development Ashling Holland will be among the presenters.
The presentations will be available on PepGen's website after the conference.