secwatch.observer — SEC 8-K summary
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Issuer:     PepGen Inc. (PEPG)
CIK:        0001835597
Form:       8-K
Filed at:   2026-03-04T23:59:59+00:00
Accession:  0001193125-26-091503
Event type: regulatory
Sentiment:  negative
Materiality: 0.80
Item codes: 2.02, 8.01, 9.01
LLM model:  deepseek-v4-flash:cloud@v2

PepGen reports FY2025 net loss $89.7M; FDA partial hold on FREEDOM2 trial
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- 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.

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1835597/000119312526091503/0001193125-26-091503-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1835597/000119312526091503/pepg-20260304.htm
  HTML page:      https://secwatch.observer/filing/0001193125-26-091503

License: Source filings: public domain (SEC EDGAR). Summaries (headline + bullets): CC-BY-4.0; attribute https://secwatch.observer