The FDA placed a partial clinical hold on PepGen’s Freedom2 Phase 2 trial for PGN‑EDODM1, a therapy for myotonic dystrophy type 1 (DM1), citing questions about previously submitted preclinical pharmacology and toxicology studies. The agency’s action does not reference human blinded clinical data, and PepGen said it is working with regulators to resolve the issues rapidly while continuing international trial activity. The partial hold prompted an almost 20% drop in PepGen shares after investors re‑priced near‑term development risk. Analysts noted the agency had seen the preclinical data before, suggesting the company’s request to open U.S. sites triggered a re‑review. PepGen emphasized that ongoing non‑U.S. sites remain active, including in New Zealand, Australia and South Korea. The FDA’s move follows a pattern of heightened scrutiny for oligonucleotide and nucleic‑acid delivery programs, particularly in neuromuscular indications. Resolution timelines will affect PepGen’s ability to recruit U.S. patients and the program’s overall development cadence.