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Sarepta Therapeutics, Inc. (NASDAQ:SRPT) shares were trading more than 3% lower after-hours following the company’s announcement, according to which the U.S. Food and Drug Administration (FDA) placed a clinical hold on SRP-5051 (vesleteplirsen) for the treatment of Duchenne muscular dystrophy.
The hold is placed on 5051-201, the Phase 2, multi-arm, ascending dose study of SRP-5051, also known as MOMENTUM, following a serious adverse event of hypomagnesemia.
The company said it will respond to the FDA in the next few days with the requested information on all cases of hypomagnesemia, including a small number of non-serious grade 2 cases, to assess the adequacy of the risk mitigation and safety monitoring plan.
