The Food and Drug Administration will not allow Sarepta (SRPT) to bring its gene therapy Elevidys, back to the market until the company can prove it will not cause more deaths, Robert Langreth and Damian Garde of Bloomberg report, citing an official familiar with the situation. The FDA has not seen a convincing explanation as to why the gene therapy was tied to two fatal cases of liver failure, and there may be no easily addressable problem the company can quickly fix, the official told Bloomberg. The third fatal case of liver failure in a Phase I trial is relevant information to the safety of Elevidys, the person added. Shares of Sarepta are down 19%, or $2.54, to $10.78 in midday trading.
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