secwatch.observer — SEC 8-K summary
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Issuer:     PepGen Inc. (PEPG)
CIK:        0001835597
Form:       8-K
Filed at:   2025-01-29T23:59:59+00:00
Accession:  0000950170-25-010515
Event type: regulatory
Sentiment:  negative
Materiality: 0.70
Item codes: 8.01, 9.01
LLM model:  deepseek-v4-flash:cloud@v2

PepGen gets FDA clinical hold on CONNECT2 U.S. trial; Health Canada restricts dose escalation in CONNECT1
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- 10 mg/kg cohort fully enrolled (n=4); data expected year-end 2025.
- One participant had eGFR reduction; dosing paused, eGFR improving.
- Health Canada allows continued dosing at current levels but requests additional info before escalation.
- FDA placed clinical hold on U.S. CONNECT2 trial; company working to address agency questions.
- All treatment-related adverse events mild per Jan 23, 2025 update by CMO Paul Streck.

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1835597/000095017025010515/0000950170-25-010515-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1835597/000095017025010515/pepg-20250129.htm
  HTML page:      https://secwatch.observer/filing/0000950170-25-010515

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