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. (PEPG) is a clinical-stage biotechnology pioneer developing next-generation oligonucleotide therapies for severe neuromuscular and neurological disorders. This page provides investors and industry observers with timely updates on the company's proprietary EDO platform advancements, clinical trial progress, and strategic initiatives.
Access consolidated information on key developments including regulatory milestones, research collaborations, and pipeline updates for candidates like PGN-EDO51 (Duchenne muscular dystrophy) and PGN-EDODM1 (myotonic dystrophy). Our news collection serves as a definitive resource for tracking the company's progress in overcoming oligonucleotide delivery challenges through engineered peptide technology.
Discover updates across three core areas: clinical trial results demonstrating therapeutic potential, peer-reviewed research validating the EDO platform's mechanisms, and strategic partnerships accelerating therapeutic development. All content is curated to help stakeholders monitor PepGen's progress in addressing critical unmet needs in genetic medicine.
Bookmark this page for streamlined access to PEPG's latest verified developments. Check regularly for updates on novel therapeutic approaches targeting muscle and central nervous system disorders through enhanced oligonucleotide delivery systems.
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.
PepGen Inc. (Nasdaq: PEPG) announced that Christopher Ashton, PhD, will retire from its Board of Directors effective September 30, 2024. Dr. Ashton has served on PepGen's Board since December 2019 and was a member of the audit and compensation committees. Laurie Keating, JD, Chair of PepGen's Board, expressed gratitude for Dr. Ashton's nearly five years of service and valuable contributions.
Dr. Ashton cited his desire to focus on guiding pre-IPO companies as the reason for his retirement. He expressed confidence in PepGen's future, noting the company's progress in developing potential best-in-class therapies for serious neuromuscular and neurological diseases. Following Dr. Ashton's resignation, the size of PepGen's Board will be reduced from seven to six directors.
PepGen Inc. (Nasdaq: PEPG), a clinical-stage biotechnology company, has awarded an inducement grant to its newly appointed Executive Vice President of Research & Development, Paul D. Streck, M.D., MBA. The grant, made under PepGen's 2024 Inducement Plan, includes a non-qualified stock option to purchase 202,816 shares of PepGen's common stock at $9.83 per share. The option has a ten-year term and will vest over four years, with 25% vesting after one year and the remainder vesting monthly over the following three years. This grant was approved outside of PepGen's stockholder-approved equity incentive plans, in accordance with Nasdaq Listing Rule 5635(c)(4).
PepGen Inc. (Nasdaq: PEPG) has appointed Paul Streck, M.D., MBA, as Executive Vice President, Head of Research & Development, effective immediately. Dr. Streck brings over 20 years of experience in drug development, regulatory, and medical affairs leadership to the clinical-stage biotechnology company. His impressive track record includes five IND approvals, six global regulatory launches, and nine commercial product launches.
Dr. Streck's extensive experience spans both large and small publicly traded biopharmaceutical companies, including roles as Chief Medical Officer at Albireo Pharma, Arena Pharmaceuticals, Alder Biopharmaceuticals, and Insmed. He has also held positions at GSK, Shire, and Amgen. This appointment comes at a important time for PepGen as they advance four active clinical trials and expand their pipeline of preclinical candidates in the field of oligonucleotide therapies for severe neuromuscular and neurological diseases.
PepGen Inc. (Nasdaq: PEPG) reported Q2 2024 financial results and corporate highlights. Key points:
1. CONNECT1-EDO51 trial: PGN-EDO51 at 5 mg/kg was well-tolerated, achieving mean exon skipping of 2.15% and mean dystrophin production increase of 0.26% after three months.
2. FREEDOM2-DM1 trial cleared by Health Canada and U.K. regulators, with initial dosing expected in H2 2024.
3. FREEDOM-DM1 trial results update expected in Q4 2024.
4. Financial position: $161.3 million in cash and equivalents as of June 30, 2024, expected to fund operations into 2026.
5. Q2 2024 net loss: $28.3 million, or $(0.87) per share.
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