Update
$PepGen (PEPG.US)$ The FDA Has Lifted The Full Clinical Hold And Cleared PepGen's Investigational New Drug Application To Initiate The FREEDOM-DM1 Phase 1 Study Of PGN-EDODM1 For Myotonic Dystrophy Type 1![]()
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Trytosaveabit OP : – Lifting of FDA hold allows FREEDOM-DM1 study to launch in the U.S. with target dose levels of 5 mg/kg, 10 mg/kg and 20 mg/kg –
– Safety, transcript splicing and clinical outcome measures data at 5 mg/kg PGN-EDODM1 dose level in patients from FREEDOM-DM1 clinical study expected in 2024 –
– Continue to expect safety, muscle exon skipping and dystrophin data at 5 mg/kg PGN-EDO51 dose level in patients from CONNECT1-EDO51 clinical study in mid-2024 –
– Cash runway expected to fund operations into 2025 –