The FDA placed a partial clinical hold on PepGen’s Freedom2‑DM1 Phase II study after re‑examining preclinical toxicology data, pausing U.S. enrollment while permitting work to continue in other countries. The agency’s focus appears centered on previously submitted mouse findings rather than the company’s blinded human data. PepGen said it will provide additional analyses, including recently unblinded Freedom data, and work to resolve the hold quickly. Analysts flagged the timing as puzzling because the animal data were on file for months; the market reacted with a near‑20% drop in PepGen shares. PepGen’s program uses Enhanced Delivery Oligonucleotide technology for myotonic dystrophy type 1 (DM1); the partial hold is procedural but underscores FDA scrutiny of oligonucleotide delivery platforms and preclinical safety signals for neuromuscular indications.