PepGen Inc

PepGen Inc. develops oligonucleotide therapies. It is a clinical-stage biotechnology company advancing the next generation of oligonucleotide therapeutics with the goal of transforming the treatment of severe neuromuscular and neurologic diseases. The company was founded in March 26, 2018 and is headquartered in Cambridge, MA.

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PepGen Inc. develops oligonucleotide therapies. It is a clinical-stage biotechnology company advancing the next generation of oligonucleotide therapeutics with the goal of transforming the treatment of severe neuromuscular and neurologic diseases. The company was founded in March 26, 2018 and is headquartered in Boston, MA.

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.

Mary Beth DeLena Joins PepGen as General Counsel and Secretary

- 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 -

PepGen Announces First Patient Dosed in CONNECT1-EDO51 Phase 2 Clinical Trial of PGN-EDO51 for Duchenne Muscular Dystrophy Patients Amenable to Exon 51 Skipping

- 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 -

PepGen Announces First Patient Dosed in Phase 1 FREEDOM-DM1 Clinical Trial of PGN-EDODM1 for Myotonic Dystrophy Type 1 (DM1)

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.

PepGen Announces Appointment of Howard Mayer, M.D. to Board of Directors

- Continuing to open CONNECT1-EDO51 trial sites in Canada - - Opening of FREEDOM-DM1 trial sites underway in the U.S. and Canada - - Ended third quarter 2023 with cash and cash equivalents of $129.5 million; cash runway expected into 2025 - BOSTON, Nov. 08, 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 reported financial results for the third quarter ended September 30, 2023 and highlighted recent corporate developments. “We made significant progress across our pipeline of Enhanced Delivery Oligonucleotide (EDO) candidate therapeutics in the third quarter of 2023, including positive news from regulatory authorities that enable the launch of our FREEDOM-DM1 study in the U.S. and Canada,” said James McArthur, Ph.D.

PepGen Reports Third Quarter 2023 Financial Results and Recent Corporate Developments

– 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 –

PepGen Inc. Announces FDA has Lifted the Clinical Hold on its Investigational New Drug Application for FREEDOM-DM1 Phase 1 Study of PGN-EDODM1 for Myotonic Dystrophy Type 1 (DM1)

PepGen is a small-cap healthcare company focused on developing therapies for genetic disorders, particularly Duchenne muscular dystrophy. The company's Enhanced Delivery Oligonucleotide platform shows promising results in increasing the delivery and efficacy of therapeutic agents for neuromuscular diseases. PepGen's pipeline includes two clinical-stage programs, PGN-EDO51 for DMD and PGN-EDODM1 for myotonic dystrophy type 1, with potential to revolutionize treatment options in these areas.

PepGen: Unearthing A Potential Trailblazer With An Attractive Risk-Reward

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:

PepGen Announces Upcoming Presentations at the 28th Annual Congress of the World Muscle Society and the World Congress of Neurology

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

PepGen Inc. Announces Clearance of CTA by Health Canada to Begin the FREEDOM-DM1 Phase 1 Study of PGN-EDODM1 in Patients with Myotonic Dystrophy Type 1

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

PepGen Inc. Presents PGN-EDODM1 Preclinical Data Supporting the Company's Enhanced Delivery Oligonucleotide Platform and PGN-EDODM1 Program at Two Medical Conferences

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.

PepGen Announces Presentations at the 2023 Myotonic Dystrophy Foundation Annual Conference, Ottawa Neuromuscular Disease Meeting, and H.C. Wainwright 25th Annual Global Investment Conference

– Phase 2 open-label CONNECT1-EDO51 study open in Canada – – Potentially registrational, randomized, double-blind, placebo-controlled Phase 2 CONNECT2-EDO51 multinational study expected to be initiated in the second half of 2023 – – Continue to pursue global strategy of initiating FREEDOM-EDODM1 clinical study in geographies outside the U.S. – – Continue to work closely with FDA to lift the clinical hold and initiate the Phase 1 FREEDOM-EDODM1 study in the U.S. as quickly as feasible – – Ended second quarter 2023 with cash and cash equivalents of $147.0 million; cash runway expected into 2025 – BOSTON, Aug. 08, 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 reported financial results for the second quarter ended June 30, 2023 and highlighted recent corporate developments. “PepGen continues to make strong progress across our pipeline of clinical and pre-clinical stage conjugated oligonucleotide therapies for neuromuscular and neurological diseases," said James McArthur, Ph.D.

PepGen Reports Second Quarter 2023 Financial Results and Recent Corporate Developments

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.

PepGen Inc. Provides Update on Planned Initiation of Phase 1 Study of PGN-EDODM1 in Myotonic Dystrophy Type 1

PepGen (PEPG) shares fall after FDA places clinical hold on a study evaluating potential treatment for myotonic dystrophy.

PepGen (PEPG) Down on Clinical Hold for DM1 Candidate

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.

PepGen Inc. Announces Clinical Hold in the U.S. on IND Application to Initiate a Phase 1 Study of PGN-EDODM1 for Myotonic Dystrophy Type 1 (DM1)

- 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 -

PepGen Announces Clearance by Health Canada of CTA for PGN-EDO51 to Begin the Phase 2 Clinical Trial, CONNECT1-EDO51, for the Treatment of Duchenne Muscular Dystrophy

– Phase 2 open-label CONNECT1-EDO51 study expected to be initiated in Canada in the first half of 2023 – – Potentially registration-directed, randomized, double-blind, placebo-controlled Phase 2 CONNECT2-EDO51 multinational study expected to be initiated in the second half of 2023 – – Phase 1 randomized, double-blind, placebo-controlled FREEDOM-DM1 study expected to be initiated in the first half of 2023 – – Ended first quarter 2023 with cash, cash equivalents, and investments of $165.4 million; Cash runway expected into 2025 – BOSTON, May 11, 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 reported financial results for the first quarter ended March 31, 2023. “PepGen has had an impressive start to 2023 and anticipates a meaningful year ahead.

PepGen Reports First Quarter 2023 Financial Results and Recent Corporate Developments

BOSTON, May 04, 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 the Bank of America Securities 2023 Healthcare Conference on Thursday, May 11th at 12:20pm EDT in Las Vegas, Nevada.

PepGen to Participate in the Bank of America Securities 2023 Healthcare Conference

BOSTON, April 17, 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 2023 American Academy of Neurology (AAN) Annual Meeting, taking place on April 22-27, 2023 in Boston, Massachusetts.

PepGen Announces Upcoming Data Presentations at the 2023 American Academy of Neurology Annual Meeting

BOSTON, April 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 James McArthur, Ph.D., President and CEO of PepGen will present at the 22nd Annual Needham Virtual Healthcare Conference on Thursday, April 20th at 8:00am EDT.

PepGen to Participate in the 22nd Annual Needham Virtual Healthcare Conference

PepGen Inc (NASDAQ:PEPG ) Q4 2022 Earnings Conference Call March 23, 2023 4:30 PM ET Company Participants Noel Donnelly - Chief Financial Officer James McArthur - President and Chief Executive Officer Jaya Goyal - Executive Vice President, Research and Preclinical Development Michelle Mellion - Senior Vice President and Head, Clinical Development Conference Call Participants Laura Chico - Wedbush Operator Good afternoon and welcome to the PepGen Conference Call to discuss PepGen's Fourth Quarter and Full Year 2022 Financial Results and Recent Corporate Developments. At this time, all participants are in a listen-only mode.

PepGen Inc (PEPG) Q4 2022 Earnings Call Transcript

BOSTON, March 23, 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 reported financial results for the fourth quarter and full year ended December 31, 2022 and highlighted recent corporate developments.

PepGen Reports Fourth Quarter and Full Year 2022 Financial Results and Recent Corporate Developments

- In NHP, four monthly doses of 20 mg/kg of PGN-EDO51 resulted in 34.9% exon skipped transcripts in biceps; a 14-fold increase over the 2.5% exon 51 skipped transcripts observed after a single dose –

PepGen Presents Clinical and Nonclinical Data at the 2023 Annual Muscular Dystrophy Association Clinical and Scientific Conference

BOSTON, March 21, 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 Stifel's CNS Days Conference on Tuesday, March 28th at 1:30pm EST.

PepGen to Participate in the Stifel 2023 CNS Days Conference

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.

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