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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Earnings data Q4 2023

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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.

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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:

PepGen to Participate in 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.

PepGen Receives U.S. FDA Orphan Drug and Rare Pediatric Disease Designations for PGN-EDO51 for the Treatment of Duchenne Muscular Dystrophy

The mean of analysts' price targets for PepGen, Inc. (PEPG) points to a 48.6% upside in the stock. While this highly sought-after metric has not proven reasonably effective, strong agreement among analysts in raising earnings estimates does indicate an upside in the stock.

Can PepGen, Inc. (PEPG) Climb 48.62% to Reach the Level Wall Street Analysts Expect?

PepGen, Inc. (PEPG) might move higher on growing optimism about its earnings prospects, which is reflected by its upgrade to a Zacks Rank #2 (Buy).

PepGen, Inc. (PEPG) Upgraded to Buy: What Does It Mean for the Stock?

PepGen, Inc. (NASDAQ:PEPG ) Q4 2023 Earnings Conference Call March 6, 2024 4:30 PM ET Company Participants Emiko Bryant - Chief of Staff James McArthur - President and CEO Michelle Mellion - SVP and Head, Clinical Development Noel Donnelly - CFO Conference Call Participants Jenny Gonzalez-Armenta - Leerink Partners James Condulis - Stifel Tazeen Ahmad - Bank of America Laura Chico - Wedbush Ananda Ghosh - H.C. Wainwright & Company Operator Good afternoon, and welcome to PepGen's Fourth Quarter and Full Year 2023 Earnings Call to discuss its financial results and recent corporate developments.

PepGen, Inc. (PEPG) Q4 2023 Earnings Call Transcript

- 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 –

PepGen Reports Fourth Quarter and Full Year 2023 Financial Results and Recent Corporate Developments

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.

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 Duchenne Muscular Dystrophy

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.”

PepGen Receives U.S. FDA Fast Track Designation for PGN-EDODM1 for the Treatment of Myotonic Dystrophy Type 1

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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.

PepGen Announces Pricing of $80.1 Million Underwritten Offering of Common Stock

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PepGen Inc. NASDAQ: PEPG is a clinical-stage biotech focused on developing therapies for rare neuromuscular and neurological genetic diseases like Duchenne muscular dystrophy (DMD). PepGen utilizes its proprietary enhanced delivery oligonucleotide (EDO) platform to create a pipeline of disease-modifying gene therapies.

PepGen soars on Sarepta Therapeutics' Duchenne drug phase 2 data

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.

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