EMA Rejects Sarepta's Duchenne Drug as Shares Plunge 1.59% and Trading Volume Slides to 500th

On August 11, 2025, Sarepta Therapeutics (SRPT) fell 1.59%, with a trading volume of $0.20 billion, ranking 500th in the market.

The decline follows the European Medicines Agency’s (EMA) recommendation to reject ELEVIDYS, Sarepta’s drug for Duchenne muscular dystrophy, due to insufficient efficacy data from a key trial involving 125 children. The EMA noted no statistically significant improvement in movement abilities compared to the placebo group, raising doubts about the drug’s clinical value.

This decision adds to a series of setbacks for Sarepta, including a securities class action lawsuit alleging misleading statements about ELEVIDYS’s safety and efficacy. The company has faced two patient deaths linked to the drug, leading to a 36% workforce reduction and a $400 million annual cost-cutting plan. Additionally, Sarepta agreed to include a black box warning for acute liver injury on ELEVIDYS’s label following FDA discussions. These developments have intensified regulatory scrutiny and investor skepticism.

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