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# Clinical Hold on PepGen IND Application
- URL: https://www.fdaweb.com/clinical-hold-on-pepgen-ind-application/
- Published: 2023-05-31T12:00:00.000Z
- Updated: 2026-09-14T18:35:23.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5154574

FDA is placing a clinical hold on a PepGen IND application to start a Phase 1 study of its PGN-EDODM1 in patients with myotonic dystrophy Type 1\. A company [statement](https://investors.pepgen.com/news-releases/news-release-details/pepgen-inc-announces-clinical-hold-us-ind-application-initiate?ref=fdaweb.com) says the agency indicated it would provide the reason for the clinical hold in an official notice within 30 days. Company officials said they were disappointed and will work closely with FDA to lift the hold as quickly as possible.