regulatory
confidence high
sentiment negative
materiality 0.80
PepGen reports FY2025 net loss $89.7M; FDA partial hold on FREEDOM2 trial
PepGen Inc.
- FDA placed partial clinical hold on FREEDOM2-DM1 Phase 2 trial of PGN-EDODM1; questions relate to preclinical studies, not clinical data.
- Dosing of 10 mg/kg cohort continues in Canada and UK; no US patients enrolled. 5 mg/kg data expected Q1 2026, 10 mg/kg data 2H 2026.
- Cash and marketable securities $148.5M as of Dec 31, 2025, sufficient into H2 2027. Net loss $89.7M for FY2025 ($2.12 per share).
- Appointed Joseph Vittiglio as Chief Business and Legal Officer in December 2025.
- USPTO issued composition-of-matter patent for PGN-EDODM1, providing US exclusivity into H2 2042.