PepGen Receives U.S. FDA Fast Track Designation For PGN-EDODM1 For The Treatment Of DM1

(RTTNews) - Biotechnology company, PepGen Inc. (PEPG), Tuesday announced that the U.S. Food and Drug Administration or FDA has granted Fast Track designation to PGN-EDODM1, an investigational candidate for the treatment of myotonic dystrophy type 1 or DM1.

DM1, also known as Steinert's disease, is a progressively disabling, life-shortening genetic disorder, causing muscle weakness and cardiac and respiratory abnormalities.

"Following robust preclinical data, we are now evaluating PGN-EDODM1 in the ongoing FREEDOM-DM1 Phase 1 trial and expect to report preliminary data later this year. We believe that PGN-EDODM1 has the potential to be disease-modifying and improve outcomes for patients living with DM1." said James McArthur, Ph.D., President and CEO of PepGen.

Previously, the FDA had granted Orphan Drug designation to PGN-EDODM1 in September 2023, the company stated.

Currently, PepGen's stock is slipping 0.80 percent, to $13.78 on the Nasdaq.