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PepGen Inc. - PEPG STOCK NEWS

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.

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PepGen has expanded its executive team with the appointments of Afsaneh Mohebbi, Ph.D., as Senior Vice President of Portfolio and Program Management, and Dave Borah, CFA, as Senior Vice President of Investor Relations and Corporate Communications. These appointments aim to strengthen PepGen's expertise as it prepares for significant clinical milestones in the second half of the year. Dr. Mohebbi brings extensive experience from her previous roles in biotech firms, including Agios Pharmaceuticals and Shire Human Genetic Therapies. She has a proven track record in advancing clinical candidates and managing cross-functional teams. Dave Borah, CFA, comes with over 20 years of experience in investor relations and corporate communications, having served at Mural Oncology and Bicycle Therapeutics. His background includes successful equity raises and increased analyst coverage, making him a valuable addition to PepGen's strategic communications efforts.

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PepGen, a clinical-stage biotechnology company, announced two executive promotions. Michelle Mellion, M.D., is now Chief Medical Officer, and Hayley Parker, Ph.D., is the new Senior Vice President of Global Regulatory Affairs. These promotions highlight their significant contributions to PepGen's clinical and regulatory strategies. Mellion has been pivotal in advancing the company's neuromuscular programs and has a rich background in clinical development and neurology. Parker has been essential in shaping PepGen's global regulatory strategy, bringing extensive experience in regulatory affairs and rare diseases. These leadership changes aim to bolster PepGen's efforts in developing innovative oligonucleotide therapies for severe neuromuscular and neurological diseases.

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PepGen (Nasdaq: PEPG), a clinical-stage biotech company, reported its Q1 2024 financial results and recent corporate highlights. Key points include the expected mid-2024 preliminary data from the CONNECT1-EDO51 trial and second half 2024 data from the FREEDOM1-DM1 trial. PepGen raised $86.3 million from stock offerings, extending its cash runway into 2026. Research and Development expenses for Q1 2024 were $14.7 million, up from $14.4 million in Q1 2023, and General and Administrative expenses rose to $5.1 million from $3.7 million. The company reported a net loss of $18.0 million, compared to $16.3 million in Q1 2023. They had 32.4 million shares outstanding as of March 31, 2024.

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PepGen Inc. (PEPG) to participate in investor conferences to discuss advancements in oligonucleotide therapies for neuromuscular and neurological diseases.
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PepGen Inc. receives FDA orphan drug and rare pediatric disease designations for PGN-EDO51, a therapy for Duchenne muscular dystrophy, highlighting the critical need for innovative treatments in severe neuromuscular diseases.
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PepGen Inc. completes enrollment for PGN-EDO51 Phase 2 clinical trial cohorts, expects preliminary data by mid-2024. The company also initiates CONNECT2-EDO51 trial, anticipates accelerated approval. Financially, PepGen raises $80 million in a follow-on offering, extending cash runway to 2026.
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PepGen Inc. (Nasdaq: PEPG) receives authorization from MHRA to initiate Phase 2 clinical trial for PGN-EDO51 in patients with Duchenne muscular dystrophy, aiming for accelerated approval.
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PepGen Inc. receives Fast Track designation from the FDA for PGN-EDODM1, a potential therapy for myotonic dystrophy type 1. The company aims to address the root cause of the disease and improve outcomes for patients.
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PepGen Inc. announced the pricing of an underwritten offering of 7,530,000 shares of its common stock at a price to the public of $10.635 per share, with expected gross proceeds of approximately $80.1 million. The offering aims to support the company's advancement of oligonucleotide therapies for severe neuromuscular and neurological diseases.
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PepGen Inc. (Nasdaq: PEPG) has announced the appointment of Mary Beth DeLena as General Counsel and Secretary. DeLena brings over 20 years of experience advising global life science companies, with extensive expertise in business development, finance, securities, corporate governance, employment, and commercial law. Her previous roles at Alnylam Pharmaceuticals and Praecis Pharmaceuticals, as well as her legal career at Skadden, Arps, Slate, Meagher & Flom LLP, demonstrate her significant contributions to the growth and success of these companies. Mary Beth's appointment is expected to play a crucial role in advancing PepGen's goal of delivering next-generation oligonucleotide therapies for severe neuromuscular and neurological diseases.
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FAQ

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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