PepGen gets FDA Fast Track for PGN-EDODM1 in DM1; Phase 1 data due 2024

PepGen Inc.

FDA granted Fast Track designation for PGN-EDODM1 targeting myotonic dystrophy type 1 (DM1).
No approved therapies target root cause of DM1; PGN-EDODM1 aims to be disease-modifying.
Ongoing FREEDOM-DM1 Phase 1 trial (NCT06204809); preliminary data expected in 2024.
PGN-EDODM1 previously received FDA Orphan Drug Designation in September 2023.

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