NEW YORK (AP) — Shares of Sarepta Therapeutics surged Monday after the company said it plans to file for marketing approval of its muscle disorder drug eteplirsen by year-end.
The Cambridge, Mass., company wanted to file for approval of eteplirsen in the first half of the year, but the Food and Drug Administration told Sarepta that that would be premature. After additional meetings with the FDA, Sarepta says it will gather more data about the drug and run a new study to confirm its previous findings about eteplirsen. It also plans to start several new clinical trials of the drug later this year.
Sarepta shares advanced $11.12, or 46 percent, to $35.52 in morning trading. Earlier the shares peaked at $40.
Sarepta Therapeutics Inc. is studying eteplirsen as a treatment for Duchenne muscular dystrophy, a rare and fatal genetic disease that causes increasing muscle weakness. It affects one of every 3,500 boys born worldwide. Eteplirsen is the company's most advanced experimental drug.
The Cambridge, Mass., company said one of its upcoming studies will include patients between the ages of 7 and 16 who can walk a minimum distance. Two other studies will evaluate patients age 7 and younger who can't walk a minimum distance or who can no longer walk at all. Sarepta also intends to start a study involving a follow-on drug.
Source : http://www.businessweek.com/ap/2014-04-21/sarepta-jumps-on-progress-for-muscle-disorder-drug
