Sarepta’s Exondys 51 Successor On Clinical Hold, But Quick Resolution Expected

As it works to expand its Duchenne muscular dystrophy (DMD) franchise on multiple fronts, Sarepta Therapeutics, Inc. is facing what may be a temporary setback as the US Food and Drug Administration placed a clinical hold on a Phase II study of SRP-5051 (vesletplirsen), its Exondys 51 successor, but the company anticipates a quick resolution of the hold and expects timelines for the drug to remain on track.

The Cambridge, MA-based firm announced the hold on Part B of the Phase II MOMENTUM study testing SRP-5051, Sarepta’s most advanced peptide-conjugated phosphorodiamidate morpholino oligomer (PPMO) therapeutic, which it thinks...