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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 (NASDAQ: 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.

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