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 dedicated to transforming the treatment of severe neuromuscular and neurologic diseases through innovative oligonucleotide therapeutics. The company's proprietary Enhanced Delivery Oligonucleotide (EDO) platform is designed to significantly enhance the uptake and activity of conjugated oligonucleotide therapeutics. This advanced platform leverages EDO peptides to optimize tissue penetration, cellular uptake, and nuclear delivery, enabling the transport of oligonucleotides into a variety of target tissues, including smooth, skeletal, and cardiac muscle, as well as the central nervous system.
PepGen’s leading product candidate is PGN-EDO51, which is currently being evaluated in the CONNECT1-EDO51 Phase 2 multiple ascending dose (MAD) clinical trial for the treatment of Duchenne muscular dystrophy (DMD) patients amenable to exon 51 skipping therapy. This trial marks a significant milestone as the first patient has been dosed, and initial data readout is expected in mid-2024. PGN-EDO51 has shown promising results in Phase 1 trials, demonstrating high levels of exon 51 skipping and a good safety profile.
Another key product in PepGen’s pipeline is PGN-EDODM1, which targets myotonic dystrophy type 1 (DM1). The FREEDOM-DM1 Phase 1 clinical trial is currently underway, with initial data anticipated in 2024. PGN-EDODM1 aims to restore cellular function by delivering a peptide-conjugated antisense oligonucleotide to address the root cause of DM1.
In addition to these, PepGen is developing PGN-EDO53 and PGN-EDO45 for other DMD patients, addressing exon 53 and 45 skipping, respectively.
Financially, PepGen has secured substantial backing through an $80 million underwritten offering of common stock, which will support ongoing research and clinical development. The company’s strategic partnerships with top-tier institutional investors and prominent biotech firms further strengthen its position in the market.
PepGen’s commitment to advancing therapeutic options for debilitating diseases is underscored by its ongoing research and development efforts, robust clinical pipeline, and strategic collaborations. The company continues to drive forward with the aim of delivering impactful therapies to patients with limited treatment options.
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.
PepGen Inc. (Nasdaq: PEPG) announced positive clinical data from the first dose cohort (5 mg/kg) of PGN-EDO51, its lead candidate for Duchenne muscular dystrophy (DMD) patients amenable to exon 51-skipping. In the CONNECT1-EDO51 Phase 2 trial, PGN-EDO51 showed:
- Mean exon skipping levels of 2.15% after three months
- Mean muscle-adjusted dystrophin level of 1.49%, a 0.70% increase from baseline
- Mean absolute dystrophin level of 0.61%, a 0.26% increase from baseline
The 5 mg/kg dose was well-tolerated, with all patients continuing to the long-term extension. Dosing of the second cohort at 10 mg/kg is ongoing. PepGen plans to optimize the design of the CONNECT2 Phase 2 trial based on these results.
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