“We made significant progress across our pipeline of Enhanced Delivery Oligonucleotide candidate therapeutics in the third quarter of 2023, including positive news from regulatory authorities that enable the launch of our FREEDOM-DM1 study in the U.S. and Canada,” said James McArthur, Ph.D., President and CEO of PepGen. “We were pleased to have been cleared by the U.S. Food and Drug Administration (FDA) to conduct the FREEDOM-DM1 study at target dose levels, 5 mg/kg, 10 mg/kg, and 20 mg/kg, that we believe could benefit patients in a clinically meaningful way. In addition, we were happy to report that the FDA granted Orphan Drug Designation to PGN-EDODM1 for the treatment of myotonic dystrophy type 1.”
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Read More on PEPG:
- PepGen Reports Third Quarter 2023 Financial Results and Recent Corporate Developments
- PepGen Inc. Announces FDA has Lifted the Clinical Hold on its Investigational New Drug Application for FREEDOM-DM1 Phase 1 Study of PGN-EDODM1 for Myotonic Dystrophy Type 1 (DM1)
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