PepGen
Cambridge
MA
United States
62 articles about PepGen
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PepGen to Participate in Upcoming Investor Conferences - March 13, 2024
3/13/2024
PepGen Inc. announced that management will participate in the following upcoming investor conferences.
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PepGen Receives U.S. FDA Orphan Drug and Rare Pediatric Disease Designations for PGN-EDO51 for the Treatment of Duchenne Muscular Dystrophy
3/13/2024
PepGen Inc. announced that the U.S. Food and Drug Administration granted both orphan drug and rare pediatric disease designations for PGN-EDO51, an investigational therapeutic for Duchenne muscular dystrophy patients whose mutations are amenable to an exon 51 skipping approach.
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PepGen Reports Fourth Quarter and Full Year 2023 Financial Results and Recent Corporate Developments
3/6/2024
PepGen Inc. (Nasdaq: PEPG) today reported financial results for the fourth quarter and full year ended December 31, 2023, and highlighted recent corporate developments.
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PepGen Announces Clearance of CTA by UK Medicines & Healthcare Products Regulatory Agency to Begin CONNECT2-EDO51, a Phase 2 Clinical Trial designed to support potential accelerated approval of PGN-EDO51 for the Treatment of DMD
3/4/2024
PepGen Inc. announced that the UK Medicines & Healthcare products Regulatory Agency has authorized its Clinical Trial Application to initiate the CONNECT2-EDO51 Phase 2 clinical trial of PGN-EDO51 in patients with Duchenne muscular dystrophy amenable to an exon 51-skipping approach.
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PepGen Receives U.S. FDA Fast Track Designation for PGN-EDODM1 for the Treatment of Myotonic Dystrophy Type 1
2/20/2024
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 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).
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PepGen Announces Pricing of $80.1 Million Underwritten Offering of Common Stock
2/7/2024
PepGen Inc. 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.
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Mary Beth DeLena Joins PepGen as General Counsel and Secretary
1/17/2024
PepGen Inc. announced the expansion of its executive team with the appointment of Mary Beth DeLena as General Counsel and Secretary.
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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
1/8/2024
PepGen Inc. announced that the first patient has been dosed in its CONNECT1-EDO51 Phase 2, open-label multiple ascending dose clinical trial evaluating PGN-EDO51 for the treatment of Duchenne muscular dystrophy patients amendable to an exon 51 skipping therapy.
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PepGen Announces First Patient Dosed in Phase 1 FREEDOM-DM1 Clinical Trial of PGN-EDODM1 for Myotonic Dystrophy Type 1 (DM1)
12/18/2023
PepGen Inc. (Nasdaq: PEPG) today announced that the first patient has been dosed in its Phase 1 clinical trial, FREEDOM-DM1, evaluating PGN-EDODM1 for the treatment of DM1.
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PepGen Announces Appointment of Howard Mayer, M.D. to Board of Directors
11/15/2023
PepGen Inc. today announced the appointment of Howard Mayer, M.D. to the PepGen Board of Directors, effective November 15, 2023.
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PepGen Reports Third Quarter 2023 Financial Results and Recent Corporate Developments
11/8/2023
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.
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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)
10/12/2023
PepGen Inc. today announced that the U.S. Food and Drug Administration (FDA) has lifted the full clinical hold and cleared the Company’s Investigational New Drug Application (IND) 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 Announces Upcoming Presentations at the 28th Annual Congress of the World Muscle Society and the World Congress of Neurology
9/27/2023
PepGen Inc. 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.
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PepGen Inc. Presents PGN-EDODM1 Preclinical Data Supporting the Company’s Enhanced Delivery Oligonucleotide Platform and PGN-EDODM1 Program at Two Medical Conferences
9/6/2023
PepGen Inc. today announced key highlights from the upcoming presentation of preclinical non-human primate (NHP) data supporting PepGen’s proprietary Enhanced Delivery Oligonucleotide (EDO) platform at the 6th Ottawa International Conference on Neuromuscular Disease and Biology (NMD) being held on September 7-9, 2023.
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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
9/6/2023
PepGen Inc. announced it has received a No Objection Letter from Health Canada for its Clinical Trial Application to initiate the FREEDOM-DM1 Phase 1 study of PGN-EDODM1 in patients with myotonic dystrophy type 1.
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PepGen Announces Presentations at the 2023 Myotonic Dystrophy Foundation Annual Conference, Ottawa Neuromuscular Disease Meeting, and H.C. Wainwright 25th Annual Global Investment Conference
9/1/2023
PepGen Inc. announced that it will be presenting at upcoming medical meetings and an investor conference.
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PepGen Reports Second Quarter 2023 Financial Results and Recent Corporate Developments
8/8/2023
PepGen Inc. today reported financial results for the second quarter ended June 30, 2023 and highlighted recent corporate developments.
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PepGen Inc. Provides Update on Planned Initiation of Phase 1 Study of PGN-EDODM1 in Myotonic Dystrophy Type 1
6/13/2023
PepGen Inc. (Nasdaq: PEPG) 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.
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The regulator will provide PepGen with a letter within 30 days explaining why a clinical hold was placed on the company’s Phase 1 study of patients with myotonic dystrophy Type 1.
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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)
5/30/2023
PepGen Inc. (Nasdaq: PEPG) 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).