Sarepta Therapeutics mentioned Thursday it was told that an adverse event report was erroneously registered with the U.S. health regulator concerning an ongoing study of the corporate’s gene remedy for Duchenne Muscular Dystrophy.
Shares of the corporate declined up to 19% earlier after a notice from the Food and Drug Administration (FDA) confirmed a patient in the research was reported to have developed severe illness. The stock cut losses to shut down about 7% after the corporate’s assertion.
Sarepta mentioned its probe indicated the report was not submitted by its worker or the study’s primary investigator.
The incident, which took place in February, involved a 7-year-old boy who developed rhabdomyolysis, a severe condition that may result in issues such as kidney failure. The boy was hospitalized for observation and discharged the next day, with test outcomes returning to baseline, the company stated.
The illness was reported in the FDA adversarial events records, which by itself cannot decide whether a drug is a reason for a problem; however, can signal potential dangers that warrant a probe.
The FDA said that it was looking into the matter and mentioned it does not have further information on it.
Sarepta said the study includes two arms with one taking the drug and the other placebo, and the patient may have been on either.
The event is unlikely to be a serious concern as there’s a chance that it might have occurred in a sufferer on placebo, said, Brian Abrahams, an analyst RBC Capital Markets.