Articles from PepGen Inc.

PepGen Inc. (Nasdaq: PEPG), a clinical-stage biotechnology company advancing the next generation of oligonucleotide therapies with the goal of transforming the treatment of severe neuromuscular and neurological diseases, today provided recent updates on its CONNECT clinical program investigating PGN-EDO51 in Duchenne muscular dystrophy (DMD) for patients amenable to an exon-51 skipping approach.

PepGen Inc. (Nasdaq: PEPG), a clinical-stage biotechnology company advancing the next generation of oligonucleotide therapies with the goal of transforming the treatment of severe neuromuscular and neurological diseases, today announced that the Company received a clinical hold notice from the U.S. Food and Drug Administration (FDA) regarding its Investigational New Drug (IND) application to initiate the CONNECT2-EDO51 clinical trial in patients with Duchenne muscular dystrophy (DMD). The FDA indicated they will provide an official clinical hold letter to the Company within 30 days.

PepGen Inc. (Nasdaq: PEPG), a clinical-stage biotechnology company advancing the next generation of oligonucleotide therapies with the goal of transforming the treatment of severe neuromuscular and neurological diseases, today announced it awarded an inducement grant under PepGen’s 2024 Inducement Plan as a material inducement to employment to its newly appointed Senior Vice President, Clinical Development, Steve Han, MD, PhD, MMSc.

PepGen Inc. (Nasdaq: PEPG), a clinical-stage biotechnology company advancing the next generation of oligonucleotide therapies with the goal of transforming the treatment of severe neuromuscular and neurological diseases, today reported financial results and recent corporate highlights for the quarter ended September 30, 2024.

PepGen Inc. (Nasdaq: PEPG), a clinical-stage biotechnology company advancing the next generation of oligonucleotide therapies with the goal of transforming the treatment of severe neuromuscular and neurological diseases, today announced that management will participate in the following upcoming investor conferences:

PepGen Inc. (Nasdaq: PEPG), a clinical-stage biotechnology company advancing the next generation of oligonucleotide therapies with the goal of transforming the treatment of severe neuromuscular and neurological diseases, today announced that the Company will be presenting a short oral presentation as well as five posters at the 29th Annual Congress of the World Muscle Society (WMS), being held October 8-12, 2024 in Prague, Czech Republic.

PepGen Inc. (Nasdaq: PEPG), a clinical-stage biotechnology company advancing the next generation of oligonucleotide therapies with the goal of transforming the treatment of severe neuromuscular and neurological diseases, today announced that Christopher Ashton, PhD, intends to retire from the Board of Directors effective September 30, 2024. Dr. Ashton has served on PepGen's Board of Directors since December 2019 and was a member of the audit and compensation committees.

PepGen Inc. (Nasdaq: PEPG), a clinical-stage biotechnology company advancing the next generation of oligonucleotide therapies with the goal of transforming the treatment of severe neuromuscular and neurological diseases, today announced it awarded an inducement grant under PepGen’s 2024 Inducement Plan as a material inducement to employment to its newly appointed Executive Vice President, Research & Development, Paul D. Streck, M.D., MBA.

PepGen Inc. (Nasdaq: PEPG), a clinical-stage biotechnology company advancing the next generation of oligonucleotide therapies with the goal of transforming the treatment of severe neuromuscular and neurological diseases, today announced the appointment of Paul Streck, M.D., MBA, as Executive Vice President, Head of Research & Development (R&D), effective immediately. Dr. Streck will join the PepGen Executive Team and will be responsible for leading the R&D organization.

PepGen Inc. (Nasdaq: PEPG), a clinical-stage biotechnology company advancing the next generation of oligonucleotide therapies with the goal of transforming the treatment of severe neuromuscular and neurological diseases, today reported financial results and recent corporate highlights for the quarter ended June 30, 2024.

PepGen Inc. (Nasdaq: PEPG), a clinical-stage biotechnology company advancing the next generation of oligonucleotide therapies with the goal of transforming the treatment of severe neuromuscular and neurological diseases, today announced positive clinical data from the first dose cohort (5 mg/kg) of PGN-EDO51, its lead investigational candidate for patients with Duchenne muscular dystrophy (DMD) whose mutations are amenable to an exon 51-skipping approach. In the ongoing CONNECT1-EDO51 Phase 2 open-label trial, PGN-EDO51 demonstrated higher levels of exon skipping than previously reported studies with other oligonucleotide therapies at similar PMO dose levels in DMD patients. The Company also reported that change from baseline in total dystrophin production and muscle-adjusted dystrophin production was comparable to, or higher than, previously reported studies with other oligonucleotide therapies at similar PMO dose levels in DMD patients. Today at 4:30 p.m. ET, the Company will host a conference call with the CONNECT1 lead investigator Dr. Hugh McMillan to discuss the data being presented.

PepGen Inc. (Nasdaq: PEPG), a clinical-stage biotechnology company advancing the next generation of oligonucleotide therapies with the goal of transforming the treatment of severe neuromuscular and neurological diseases, today announced the expansion of its executive team with the appointments of Afsaneh Mohebbi, Ph.D., as Senior Vice President, Portfolio and Program Management and Dave Borah, CFA, as Senior Vice President, Investor Relations and Corporate Communications, effective immediately.

PepGen Inc. (Nasdaq: PEPG), a clinical-stage biotechnology company advancing the next generation of oligonucleotide therapies with the goal of transforming the treatment of severe neuromuscular and neurological diseases, today announced two executive team promotions effective immediately: Michelle Mellion, M.D., to Chief Medical Officer and Hayley Parker, Ph.D., to Senior Vice President, Global Regulatory Affairs.

– CONNECT1-EDO51 trial preliminary data from 5mg/kg dose cohort expected mid-2024 –

BOSTON, March 13, 2024 (GLOBE NEWSWIRE) -- PepGen Inc. (Nasdaq: PEPG), a clinical-stage biotechnology company advancing the next generation of oligonucleotide therapies with the goal of transforming the treatment of severe neuromuscular and neurological diseases, today announced that management will participate in the following upcoming investor conferences:

BOSTON, March 13, 2024 (GLOBE NEWSWIRE) -- PepGen Inc. (Nasdaq: PEPG), a clinical-stage biotechnology company advancing the next generation of oligonucleotide therapies with the goal of transforming the treatment of severe neuromuscular and neurological diseases, today announced that the U.S. Food and Drug Administration (FDA) granted both orphan drug and rare pediatric disease designations for PGN-EDO51, an investigational therapeutic for Duchenne muscular dystrophy (DMD) patients whose mutations are amenable to an exon 51 skipping approach. PepGen is evaluating PGN-EDO51 for the treatment of DMD in the ongoing CONNECT1 Phase 2 trial, and expects to begin enrolling patients in the CONNECT2 Phase 2 trial later this year.

- Enrollment completed for PGN-EDO51 5 mg/kg cohort in CONNECT1-EDO51 Phase 2 clinical trial in DMD patients. The Company expects to announce preliminary data from the 5 mg/kg dose cohort in mid-2024 –

BOSTON, March 04, 2024 (GLOBE NEWSWIRE) -- PepGen Inc. (Nasdaq: PEPG), a clinical-stage biotechnology company advancing the next generation of oligonucleotide therapies with the goal of transforming the treatment of severe neuromuscular and neurological diseases, today announced that the UK Medicines & Healthcare products Regulatory Agency (MHRA) has authorized its Clinical Trial Application (CTA) to initiate the CONNECT2-EDO51 Phase 2 clinical trial of PGN-EDO51 in patients with Duchenne muscular dystrophy (DMD) amenable to an exon 51-skipping approach.

BOSTON, Feb. 20, 2024 (GLOBE NEWSWIRE) -- PepGen Inc. (Nasdaq: PEPG), a clinical-stage biotechnology company advancing the next generation of oligonucleotide therapies with the goal of transforming the treatment of severe neuromuscular and neurological diseases, today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to PGN-EDODM1, an investigational candidate for the treatment of myotonic dystrophy type 1 (DM1). “Receiving Fast Track designation from the FDA for PGN-EDODM1 is a significant milestone in our efforts to deliver a potentially transformative therapy to the DM1 community,” said James McArthur, Ph.D., President and CEO of PepGen. “Patients with DM1 currently have no available treatment options that target the root cause of the disease, which leads to progressive neuromuscular symptoms and reduction in life expectancy. Following robust preclinical data, we are now evaluating PGN-EDODM1 in the ongoing FREEDOM-DM1 Phase 1 trial and expect to report preliminary data later this year. We believe that PGN-EDODM1 has the potential to be disease-modifying and improve outcomes for patients living with DM1.”

BOSTON, Feb. 07, 2024 (GLOBE NEWSWIRE) -- PepGen Inc. (Nasdaq: PEPG), a clinical-stage biotechnology company advancing the next generation of oligonucleotide therapies with the goal of transforming the treatment of severe neuromuscular and neurological diseases, today 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. The aggregate gross proceeds to PepGen from this offering are expected to be approximately $80.1 million, before deducting underwriting discounts and commissions and offering expenses payable by PepGen. The offering is expected to close on or about February 9, 2024, subject to customary closing conditions.

BOSTON, Jan. 17, 2024 (GLOBE NEWSWIRE) -- PepGen Inc. (Nasdaq: PEPG), a clinical-stage biotechnology company advancing the next generation of oligonucleotide therapies with the goal of transforming the treatment of severe neuromuscular and neurological diseases, today announced the expansion of its executive team with the appointment of Mary Beth DeLena as General Counsel and Secretary. Ms. DeLena joins PepGen with over 20 years of experience advising global life science companies in a broad range of strategic, transactional, and corporate matters with extensive experience in business development, finance, securities, corporate governance, employment and commercial law.

- Preliminary data from the 5 mg/kg PGN-EDO51 dose level in the CONNECT1-EDO51 Phase 2 trial are expected mid-2024: including initial safety, exon 51 skipping and dystrophin protein production data -

- Safety, transcript splicing correction and clinical outcome measures data at 5 mg/kg PGN-EDODM1 dose level in patients from FREEDOM-DM1 clinical trial expected in 2024 -

BOSTON, Nov. 15, 2023 (GLOBE NEWSWIRE) -- PepGen Inc. (Nasdaq: PEPG), a clinical-stage biotechnology company advancing the next generation of oligonucleotide therapies with the goal of transforming the treatment of severe neuromuscular and neurological diseases, today announced the appointment of Howard Mayer, M.D. to the PepGen Board of Directors, effective November 15, 2023.

- Continuing to open CONNECT1-EDO51 trial sites in Canada -

– Lifting of FDA hold allows FREEDOM-DM1 study to launch in the U.S. with target dose levels of 5 mg/kg, 10 mg/kg and 20 mg/kg –

BOSTON, Sept. 27, 2023 (GLOBE NEWSWIRE) -- PepGen Inc. (Nasdaq: PEPG), a clinical-stage biotechnology company advancing the next generation of oligonucleotide therapies with the goal of transforming the treatment of severe neuromuscular and neurological diseases, today announced that it will be presenting at the 28th Annual Congress of the World Muscle Society, being held October 3-7 in Charleston, South Carolina. Details of the presentations can be found below:

The U.S. Food and Drug Administration (FDA) granted Orphan Drug Designation to PGN-EDODM1 for the treatment of Myotonic Dystrophy Type 1 (DM1)

- EDO platform observed to drive 25-fold higher level of oligonucleotide delivery to myotube nuclei compared to “naked” oligonucleotide -

BOSTON, Sept. 01, 2023 (GLOBE NEWSWIRE) -- PepGen Inc. (Nasdaq: PEPG), a clinical-stage biotechnology company advancing the next generation of oligonucleotide therapies with the goal of transforming the treatment of severe neuromuscular and neurological diseases, today announced that it will be presenting at upcoming medical meetings and an investor conference. Ashling Holland, Director of Preclinical Development at PepGen, will be giving a talk titled “PGN-EDODM1 nonclinical data demonstrated mechanistic and meaningful activity for the potential treatment of myotonic dystrophy type 1 (DM1)”, at the 2023 Myotonic Dystrophy Foundation Annual Conference, on September 9, 2023, in Washington, D.C.

– Phase 2 open-label CONNECT1-EDO51 study open in Canada –

BOSTON, June 13, 2023 (GLOBE NEWSWIRE) -- PepGen Inc. (Nasdaq: PEPG), a clinical-stage biotechnology company advancing the next generation of oligonucleotide therapies with the goal of transforming the treatment of severe neuromuscular and neurological diseases, today announced that while it awaits receipt of an official clinical hold letter from the U.S. Food and Drug Administration (FDA), the Company is withdrawing its prior guidance with respect to the timeline for initiating a Phase 1 study of PGN-EDODM1 in patients with myotonic dystrophy type 1 (DM1) in the first half of 2023 in any geography.

BOSTON, May 30, 2023 (GLOBE NEWSWIRE) -- PepGen Inc. (Nasdaq: PEPG), a clinical-stage biotechnology company advancing the next generation of oligonucleotide therapies with the goal of transforming the treatment of severe neuromuscular and neurological diseases, today announced that the Company received a clinical hold notice from the U.S. Food and Drug Administration (FDA) regarding their Investigational New Drug Application (IND) to initiate a Phase 1 study of PGN-EDODM1 in patients with Myotonic Dystrophy Type 1 (DM1). The FDA indicated its intention to provide an official clinical hold letter to PepGen stating the reasons for the clinical hold within 30 days.

- CONNECT1-EDO51 will assess dystrophin levels, exon skipping data and safety data following multiple doses of PGN-EDO51 in patients with mutations amenable to skipping exon 51 -

– Phase 2 open-label CONNECT1-EDO51 study expected to be initiated in Canada in the first half of 2023 –

BOSTON, March 16, 2023 (GLOBE NEWSWIRE) -- PepGen Inc. (Nasdaq: PEPG), a clinical-stage biotechnology company advancing the next generation of oligonucleotide therapies with the goal of transforming the treatment of severe neuromuscular and neurological diseases, will report its fourth quarter and full year 2022 financial results and provide a corporate update on Thursday, March 23, 2023. PepGen’s management will host a conference call and live audio webcast to discuss these results and provide a corporate update at 4:30pm ET.

BOSTON, March 13, 2023 (GLOBE NEWSWIRE) -- PepGen Inc. (Nasdaq: PEPG), a clinical-stage biotechnology company advancing the next generation of oligonucleotide therapies with the goal of transforming the treatment of severe neuromuscular and neurological diseases, today announced that it will present at the Muscular Dystrophy Association (MDA) Annual Clinical and Scientific Conference, taking place on March 19-22, 2023 in Dallas, Texas.

BOSTON, Feb. 09, 2023 (GLOBE NEWSWIRE) -- PepGen Inc. (Nasdaq: PEPG), a clinical-stage biotechnology company advancing the next generation of oligonucleotide therapies with the goal of transforming the treatment of severe neuromuscular and neurological diseases, today announced that James McArthur, Ph.D., President and CEO of PepGen will present at SVB Securities’ Global Biopharma Virtual Conference on Thursday, February 16th 2023, at 10:40 A.M. EST.

- PGN-EDODM1 was well-tolerated in acute GLP studies in rodents and non-human primates (NHPs) at clinically relevant doses-