PepGen Stock Drops 26% After FDA Imposes Partial Clinical Hold
PepGen Inc. (NASDAQ:PEPG) saw its shares plummet by 26% in after-hours trading on Wednesday, following the U.S. Food and Drug Administration’s decision to impose a partial clinical hold on the company’s FREEDOM2-DM1 Phase 2 trial.
The FDA raised concerns about preclinical pharmacology and toxicology studies related to PGN-EDODM1, PepGen’s treatment candidate for myotonic dystrophy type 1. However, the agency did not flag any issues with the blinded clinical data from the earlier Phase 1 FREEDOM study. Notably, no U.S. patients have been enrolled in the FREEDOM2 trial so far.
In response, PepGen is actively working to address the FDA’s questions. The company is submitting additional analyses, including newly unblinded data from the FREEDOM study, to resolve the regulatory concerns. Meanwhile, the trial continues to progress internationally. PepGen has already secured regulatory clearance to initiate FREEDOM2 in South Korea, Australia, and New Zealand. Additionally, dosing of the 10 mg/kg cohort is ongoing in the UK and Canada.
The FREEDOM2 trial recently received a recommendation from the Data Safety Monitoring Board to escalate dosing. As a result, patients in Canada and the UK are now being dosed at 10 mg/kg. Furthermore, participants from both the FREEDOM and FREEDOM2 studies in Canada are transitioning into the Open Label Extension study, which has also received regulatory approval in the UK.
Despite the setback, the Boston-based biotech firm remains on track with its data reporting timeline. PepGen reiterated its guidance to release data from the FREEDOM2 5 mg/kg cohort in the first quarter of 2026, with results from the 10 mg/kg cohort expected in the second half of the year.
This development marks a significant challenge for PepGen, but the company’s ongoing efforts to address regulatory concerns and its progress in international trials highlight its commitment to advancing PGN-EDODM1 as a potential treatment for myotonic dystrophy type 1.
To find out more investors relations information about PepGen Inc. please visit www.investors.pepgen.com.
