The FDA placed a partial clinical hold on PepGen’s Phase 2 trial for a rare muscle wasting disorder, citing unresolved questions in the company’s preclinical data package. The hold affects the company’s lead and only pipeline candidate and pauses planned enrollment and dosing. PepGen acknowledged the agency’s concerns and is working to address them; analysts attributed part of the regulatory friction to resource constraints within the agency, noting potential delays for small developers who depend on steady review timelines. The action underscores the fragility of early‑stage programs where a single regulatory step can materially affect company prospects.