Sarepta Shares Rise as FDA Requests for Additional Information on Eteplirsen, a Duchenne Treatment

On Monday, Sarepta Therapeutics Inc's shares spiked during late trading hours with news that the U.S. Food and Drug Administration has asked for more information from the drug maker regarding its experimental treatment for muscular dystrophy.

Sarepta's shares climbed a sharp thirty one percent during the afterhours trading to $21.05.

In May, the FDA, which has the responsibility of the approving new medicines said there was a delay in its decision involving, eteplirsen. This sparked speculations that the agency might approve the treatment in spite of it being rejected by an advisory panel. Though it is not mandatory for the agency to follow the advice of the panel, but in most cases it does so. The recent request for extra information from the agency rekindled hopes of FDA approving the treatment.

Eteplirsen, the drug under consideration is a treatment for those who suffer from the crippling genetic condition called Duchenne muscular dystrophy. It has no effective treatments so far and destroys muscles, killing patients frequently by the age of 30s.  The disease is characterized by progressive degeneration of muscles along with weakness.  DMD results from the absence of dystrophin which is a protein that helps muscle cells to remain intact.

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