(Reuters) – Sarepta Therapeutics Inc (SRPT.O) said on Thursday it was informed that an adverse event report was erroneously submitted to the U.S. health regulator regarding an ongoing study of the company’s gene therapy for Duchenne muscular dystrophy (DMD).
Shares of the company plunged as much as 19% earlier after a notice from the Food and Drug Administration showed a patient in the study was reported to have developed a serious illness. The stock pared losses to close down about 7% after the company’s statement.
Sarepta said its investigation indicated the report was not submitted by its employee or the study’s principal investigator.
The drug safety monitoring board has recommended the study to continue after a review, the company said in a statement.
The incident, which occurred in February, involved a 7-year-old boy who developed rhabdomyolysis, a serious condition that can lead to complications such as kidney failure. The patient was hospitalized for…
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