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. develops oligonucleotide therapies for severe neuromuscular and neurological diseases. The company’s Enhanced Delivery Oligonucleotide platform uses cell-penetrating peptides to improve tissue penetration, cellular uptake and nuclear delivery of conjugated oligonucleotide therapeutics.
Recurring PepGen news centers on clinical development of PGN-EDODM1 for myotonic dystrophy type 1, including FREEDOM and FREEDOM2 study updates, safety observations, splicing correction data, regulatory communications and trial geography. Coverage also includes financial results, cash runway commentary, intellectual-property developments such as composition-of-matter patent protection, executive and governance updates, and equity compensation actions under Nasdaq rules.
PepGen (Nasdaq: PEPG) reported second quarter 2026 results and clinical progress for PGN-EDODM1 in myotonic dystrophy type 1. An independent DSMB recommended advancing the FREEDOM2 Phase 2 MAD trial to its highest 12.5 mg/kg dose cohort and approved dose escalation in the FREEDOM-OLE study from 5 mg/kg to 10 mg/kg.
The 10 mg/kg FREEDOM2 cohort is fully enrolled, with data expected in November 2026; 12.5 mg/kg cohort data are expected in 1H 2027. Cash, cash equivalents and marketable securities were $117.2 million as of June 30, 2026, which PepGen expects to fund operations into Q4 2027. Q2 2026 R&D expenses were $12.5 million versus $18.4 million a year earlier, G&A expenses were $6.4 million versus $5.5 million, and net loss was $17.8 million ($0.26 per share) versus $23.1 million ($0.70 per share). PGN-EDODM1 holds FDA Orphan Drug and Fast Track designations and EMA Orphan designation.
PepGen (Nasdaq: PEPG) reported that an independent Data and Safety Monitoring Board recommended advancing the Phase 2 FREEDOM2-DM1 study of PGN-EDODM1 in myotonic dystrophy type 1 into the third and highest multiple ascending dose cohort of 12.5 mg/kg, with no protocol changes.
The DSMB also recommended escalating dosing in the open-label extension from 5 mg/kg to 10 mg/kg. According to PepGen, PGN-EDODM1 remains generally well-tolerated, with no serious adverse events, dose-limiting toxicities, cumulative toxicity signals, or treatment discontinuations reported to date. The company expects data from the fully enrolled 10 mg/kg FREEDOM2 cohort in November, 12.5 mg/kg results in the first half of 2027, and an OLE update by early January. PepGen plans an end-of-Phase 2 regulatory meeting after 12.5 mg/kg results.
PepGen (Nasdaq: PEPG) will present new PGN-EDODM1 clinical data at the 15th International Myotonic Dystrophy Consortium (IDMC-15) in Saguenay, Canada, May 26-30, 2026.
Presentations cover individual patient mis-splicing analyses, DM1 natural history data, and FREEDOM-DM1 trial results on splicing correction and safety.
PepGen (Nasdaq: PEPG) reported Q1 2026 results and FREEDOM2-DM1 clinical progress. The 5 mg/kg cohort showed favorable safety, splicing and vHOT data, supporting the ongoing 10 mg/kg cohort, which is fully enrolled with data expected in 2H 2026.
PepGen has 13 patients in the 5 mg/kg OLE with no discontinuations and new regulatory clearances in South Korea, Australia and New Zealand. Cash and securities were $132.3M at March 31, 2026, expected to fund operations into 2H 2027. Q1 net loss was $17.8M, versus $30.2M a year earlier.
PepGen (Nasdaq: PEPG) reported topline Phase 2 FREEDOM2 5 mg/kg MAD cohort results (data cutoff March 4, 2026). PGN-EDODM1 was generally well tolerated with no serious adverse events and mainly mild TEAEs. Mean splicing correction was 7.3% (n=6) vs 6.8% placebo (n=2); excluding one outlier, treated mean was 22.9% (n=5).
Middle finger vHOT trended positively versus placebo but returned to baseline by Week 16. Mean muscle concentration in five patients was 158 ng/g. Company expects 10 mg/kg cohort data in 2H 2026 and sufficient cash into 2H 2027.
PepGen (Nasdaq: PEPG) reported 2025 year-end results and program updates highlighting clinical progress for PGN-EDODM1 in DM1 and a strong cash position. Key clinical readouts and regulatory actions are scheduled for 2026, and the company held $148.5M cash as of December 31, 2025.
Notable details: FREEDOM Phase 1 showed dose-proportional tissue exposure and splicing correction up to 53.7% at 15 mg/kg; FREEDOM2 5 mg/kg data expected Q1 2026; 10 mg/kg cohort dosing proceeding with results due 2H 2026; USPTO issued a composition-of-matter patent extending U.S. exclusivity into H2 2042.
PepGen (NASDAQ: PEPG) reported regulatory updates for the FREEDOM2 trial. The U.S. FDA placed a partial clinical hold on the FREEDOM2-DM1 Phase 2 MAD trial related to preclinical pharmacology and toxicology questions; the hold did not cite blinded FREEDOM clinical data.
PepGen is submitting additional analyses, including recently unblinded FREEDOM data, and was cleared to open FREEDOM2 in New Zealand, Australia, and South Korea. Dosing at 10 mg/kg continues in the UK and Canada; no U.S. patients are enrolled. The company expects 5 mg/kg cohort data in Q1 2026 and 10 mg/kg cohort data in 2H 2026. The FREEDOM/FREEDOM2 Canadian patients continue into an OLE, and the OLE is cleared in the UK.
PepGen (Nasdaq: PEPG) announced that President and CEO James McArthur, PhD, will participate in a fireside chat at the Leerink Global Healthcare Conference on March 10, 2026 at 3:00 p.m. ET in Miami.
A live webcast will be available on the company’s Investors "Events & Presentations" page, with a replay accessible for 90 days after the presentation.
PepGen (Nasdaq: PEPG) announced an inducement equity grant tied to the appointment of Joseph Vittiglio as Chief Business and Legal Officer.
On December 8, 2025 PepGen granted Mr. Vittiglio a non-qualified stock option to purchase 160,000 shares at an exercise price of $5.59 per share (the Nasdaq closing price on December 8, 2025). The option has a 10-year term and vests over four years: 25% on the one-year anniversary of employment and the remainder in equal monthly installments over the next three years, subject to continued service.
The award was granted under PepGen’s 2024 Inducement Plan (adopted August 2024) and was approved by the board as a material inducement in accordance with Nasdaq Listing Rule 5635(c)(4).
PepGen (Nasdaq: PEPG) appointed Joseph Vittiglio, Esq., as Chief Business and Legal Officer effective December 8, 2025. Mr. Vittiglio brings more than two decades of executive leadership in legal, compliance, corporate development, and governance for public biotech companies.
He supported PepGen as a consultant in 2025 and previously led global legal and business functions at bluebird bio, helping support approval and launch of three U.S. gene therapy products and completing $400 million+ in financings. PepGen notes he will help advance the PGN-EDODM1 program ahead of anticipated 2026 readouts from FREEDOM2-EDODM1 5 mg/kg and 10 mg/kg cohorts.