secwatch.observer — SEC 8-K summary
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Issuer:     PepGen Inc. (PEPG)
CIK:        0001835597
Form:       8-K
Filed at:   2024-12-16T23:59:59+00:00
Accession:  0000950170-24-136389
Event type: regulatory
Sentiment:  negative
Materiality: 0.80
Item codes: 8.01, 9.01
LLM model:  deepseek-v4-flash:cloud@v2

PepGen receives FDA clinical hold for Phase 2 DMD trial IND
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- FDA issued clinical hold for IND to initiate CONNECT2-EDO51 Phase 2 study of PGN-EDO51 in DMD patients.
- FDA to provide official clinical hold letter within 30 days; CONNECT2 remains open in the UK.
- Open-label CONNECT1-EDO51 study in Canada continues; 10 mg/kg cohort now fully enrolled.
- PepGen intends to work closely with FDA to address questions expeditiously.

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1835597/000095017024136389/0000950170-24-136389-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1835597/000095017024136389/pepg-20241216.htm
  HTML page:      https://secwatch.observer/filing/0000950170-24-136389

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