The FDA has granted fast track designation to an investigational peptide-conjugated antisense oligonucleotide delivery system to treat myotonic dystrophy type 1, according to the manufacturer.
According to a press release from PepGen Inc., its novel therapeutic PGN-EDODM1 is currently being evaluated in the ongoing phase 1 FREEDOM-DM1 clinical trial, for which the company expects to report initial data later this year.
Fast track designation aims to facilitate development and expedite the review of drug candidates that treat serious conditions and fill unmet or urgent medical needs, ultimately