secwatch.observer — SEC 8-K summary
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Issuer:     PepGen Inc. (PEPG)
CIK:        0001835597
Form:       8-K
Filed at:   2023-10-12T23:59:59+00:00
Accession:  0000950170-23-052999
Event type: regulatory
Sentiment:  positive
Materiality: 0.75
Item codes: 8.01, 9.01
LLM model:  deepseek-v4-flash:cloud@v2

FDA lifts clinical hold on PepGen's DM1 program; US Phase 1 trial to begin
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- FDA cleared IND for FREEDOM-DM1 Phase 1 study of PGN-EDODM1 in DM1 patients in the US.
- Target dose levels in the study: 5 mg/kg, 10 mg/kg, and 20 mg/kg.
- Proof-of-concept data (safety, transcript splicing, clinical outcomes) at 5 mg/kg expected in 2024.
- CONNECT1-EDO51 DMD study proof-of-concept data (exon skipping, dystrophin) at 5 mg/kg expected mid-2024.
- Cash and equivalents expected to fund operations into 2025.

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1835597/000095017023052999/0000950170-23-052999-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1835597/000095017023052999/pepg-20231012.htm
  HTML page:      https://secwatch.observer/filing/0000950170-23-052999

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