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PepGen Inc. - PEPG STOCK NEWS

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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.

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PepGen Inc. (Nasdaq: PEPG) announced the dosing of the first patient in its CONNECT1-EDO51 Phase 2 trial, evaluating PGN-EDO51 for the treatment of Duchenne muscular dystrophy (DMD) patients. Preliminary data from the 5 mg/kg PGN-EDO51 dose level is expected mid-2024, with Phase 1 results showing peak exon 51 skipping of 3.8% and 100% of subjects demonstrating exon skipping. The company aims to develop therapies to improve the lives of people living with DMD.
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PepGen Inc. (Nasdaq: PEPG) announces dosing of the first patient in its Phase 1 clinical trial, FREEDOM-DM1, to evaluate PGN-EDODM1 for the treatment of DM1. The company anticipates proof-of-concept data in 2024, including safety, transcript splicing, and clinical outcome measures at the 5 mg/kg dose level. The trial is intended to enroll approximately 24 adult patients with DM1 to evaluate safety, tolerability, and clinical outcomes impacted in DM1.
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PepGen Inc. (Nasdaq: PEPG) appoints Howard Mayer, M.D. to its Board of Directors. Dr. Mayer brings extensive clinical development and regulatory experience to the company, enhancing its mission to revolutionize genetic therapies for severe neuromuscular and neurological diseases.
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PepGen Inc. (Nasdaq: PEPG) reported Q3 2023 financial results, highlighting progress in clinical trials for neuromuscular and neurological diseases. Recent developments include FDA clearance for FREEDOM-DM1 study, Orphan Drug Designation, and CONNECT1-EDO51 advancements. The company ended Q3 2023 with $129.5 million in cash and cash equivalents, expected to fund operations into 2025.
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PepGen Inc. receives FDA clearance to initiate the FREEDOM-DM1 Phase 1 study of PGN-EDODM1 in patients with myotonic dystrophy type 1 (DM1) in the U.S.
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PepGen Inc. will be presenting at the 28th Annual Congress of the World Muscle Society, showcasing their advancements in oligonucleotide therapies for neuromuscular diseases.
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PepGen receives FDA orphan drug designation for PGN-EDODM1 to treat myotonic dystrophy type 1
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PepGen announces key highlights from upcoming presentations on their EDO platform for oligonucleotide therapies. EDO technology enables higher level of nuclear delivery of oligonucleotides, with 72% of muscle nuclei positive for oligonucleotide in non-human primates. PGN-EDODM1 corrected 99% of mis-splicing and reversed 99% of myotonia in a murine model. Positive potential for transforming treatment of severe neuromuscular and neurological diseases.
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PepGen Inc. reported financial results for Q2 2023, ending with $147.0 million in cash and cash equivalents. They plan to initiate the Phase 2 CONNECT2-EDO51 study in the second half of 2023. The company is pursuing a global strategy for the Phase 1 FREEDOM-EDODM1 study and working to lift the clinical hold in the U.S. They expect to report initial dystrophin production, exon skipping, and safety data from the CONNECT1 study in mid-2024.
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FAQ

What is the current stock price of PepGen (PEPG)?

The current stock price of PepGen (PEPG) is $3.63 as of December 20, 2024.

What is the market cap of PepGen (PEPG)?

The market cap of PepGen (PEPG) is approximately 134.6M.

What is PepGen Inc.?

PepGen Inc. is a clinical-stage biotechnology company that focuses on developing advanced oligonucleotide therapies for treating severe neuromuscular and neurological diseases.

What is the Enhanced Delivery Oligonucleotide (EDO) platform?

The EDO platform is PepGen’s proprietary technology designed to enhance the uptake and activity of conjugated oligonucleotide therapeutics by leveraging cell-penetrating peptides.

What are the key products in PepGen's pipeline?

PepGen's key products include PGN-EDO51 for Duchenne muscular dystrophy (DMD) and PGN-EDODM1 for myotonic dystrophy type 1 (DM1). Other products include PGN-EDO53 and PGN-EDO45.

What is the CONNECT1-EDO51 clinical trial?

CONNECT1-EDO51 is a Phase 2 multiple ascending dose (MAD) clinical trial evaluating PGN-EDO51 for the treatment of DMD patients amenable to exon 51 skipping therapy.

What achievements has PGN-EDO51 demonstrated in trials?

PGN-EDO51 has shown high levels of exon 51 skipping and a strong safety profile in Phase 1 trials, with further data expected from the CONNECT1-EDO51 trial in mid-2024.

What is the purpose of PGN-EDODM1?

PGN-EDODM1 is designed to treat myotonic dystrophy type 1 (DM1) by delivering a peptide-conjugated antisense oligonucleotide to restore normal cellular function.

How is PepGen funded?

PepGen is funded through substantial backing from institutional investors and a recent $80 million underwritten offering of common stock.

What is Duchenne muscular dystrophy (DMD)?

DMD is an X-linked recessive muscle-wasting disease predominantly affecting males, caused by genetic mutations in the gene encoding dystrophin, leading to progressive muscle weakness and early mortality.

What is myotonic dystrophy type 1 (DM1)?

DM1 is a genetic disorder characterized by progressive muscle wasting and weakness, and is the most common and severe form of myotonic dystrophy, affecting both muscle and systemic functions.

What are PepGen’s future plans?

PepGen plans to continue advancing its clinical trials for PGN-EDO51 and PGN-EDODM1, and initiate additional trials for new product candidates targeting severe neuromuscular and neurological diseases.

PepGen Inc.

Nasdaq:PEPG

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PEPG Stock Data

134.62M
29.68M
0.02%
97.91%
2.28%
Biotechnology
Pharmaceutical Preparations
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