FDA Lifts Clinical Hold On Sarepta's Dose-Expansion Part Of Duchenne Trial

The FDA has removed the clinical hold on Sarepta Therapeutics Inc's SRPT SRP-5051 (vesleteplirsen) for Duchenne muscular dystrophy who are amenable to exon 51 skipping.
After discussions with FDA and as part of the lift, Sarepta will adjust the global trial protocol to include expanded monitoring of urine biomarkers.
Also Read: Sarepta Reports One Heart Inflammation Case In Duchenne Gene Therapy Trial.
The hold in Part B of Study 5051-201, also known as MOMENTUM, followed a serious adverse event of hypomagnesemia (magnesium deficiency). The company provided information to FDA to assess the adequacy of the risk mitigation and safety monitoring plan.
MOMENTUM Phase 2 trial has continued enrolling participants outside the U.S., and the company remains on track to complete enrollment by the end of 2022.
Price Action: SRPT shares are up 0.13% at $109.52 during the premarket session on the last check Tuesday.