PepGen Inc. FREEDOM2 Trial Placed On Partial FDA Hold Related To Preclinical Pharmacology And Toxicology; Cleared To Proceed In South Korea, Australia, And New Zealand And Dosing Of The 10 mg/kg Cohort Continues In The UK And Canada; Data Expected In 2026

- U.S. FDA places FREEDOM2 trial on partial clinical hold related to preclinical pharmacology and toxicology -

- Received regulatory clearance to initiate FREEDOM2 in South Korea, Australia, and New Zealand and dosing of the 10 mg/kg cohort continues in the UK and Canada -

- PepGen reiterates guidance for reporting data from the FREEDOM2 5 mg/kg cohort in Q1 2026 and from the 10 mg/kg cohort in 2H 2026 -

PepGen Inc. (NASDAQ:PEPG), a clinical-stage biotechnology company advancing the next generation of oligonucleotide therapies to treat severe neuromuscular and neurological diseases, today announced regulatory updates related to the FREEDOM2 trial.

The U.S. Food and Drug Administration (FDA) has placed a partial clinical hold on the FREEDOM2-DM1 Phase 2 multiple ascending dose (MAD), randomized, placebo-controlled clinical trial of PGN-EDODM1 in patients with myotonic dystrophy type 1 (DM1). The partial clinical hold questions raised by FDA relate to previously submitted preclinical pharmacology and toxicology studies. The partial clinical hold did not cite any questions regarding blinded clinical data from the Phase 1 FREEDOM study previously submitted to the FDA in order to initiate the FREEDOM2 study in the U.S. As part of its ongoing dialogue with the FDA, the Company is submitting additional analyses, including the recently unblinded FREEDOM data, and is committed to working with the FDA to address their questions as quickly as possible.

PepGen was recently cleared to open the FREEDOM2 study in New Zealand, Australia, and South Korea.

Following the Data Safety Monitoring Board's recommendation to dose escalate, the FREEDOM2 trial is dosing patients at 10 mg/kg in Canada and the UK. No U.S. patients have been enrolled in FREEDOM2. Patients from the FREEDOM and FREEDOM2 studies in Canada are continuing into the Open Label Extension (OLE) study. The Company has received regulatory clearance for the OLE study in the UK and intends to open the OLE study in all geographies where FREEDOM2 is open.

The Company expects to report data from the 5 mg/kg cohort of FREEDOM2 in the first quarter of 2026, and from the 10 mg/kg cohort in the second half of 2026.