PepGen reported that the FDA placed a partial clinical hold on the Freedom2‑DM1 Phase II multiple‑ascending‑dose trial of PGN‑EDODM1 in myotonic dystrophy type 1, citing concerns in preclinical pharmacology and toxicology data rather than human blinded results. The company said it is providing additional analyses and unblinded Freedom data to address the agency’s questions; it will continue the trial at non‑U.S. sites where allowed. PepGen shares fell after the announcement; analysts noted the hold appears resolvable but underscores persistent regulatory caution around oligonucleotide delivery technologies in neuromuscular indications.