Five months after Sarepta Therapeutics lost 64 percent of its market value in one day, the company got the go-ahead to file for approval of its experimental drug for Duchenne muscular dystrophy.
Sarepta said Monday it received guidance from the Food and Drug Administration that will enable it to apply for regulatory approval of eteplirsen by the end of this year, before completing a larger scale, confirmatory clinical study. The company will supplement its FDA filing with additional safety and efficacy data from an earlier trial as well as from a confirmatory study it plans to start in the third quarter, according to a statement.
The agency's guidance comes after Sarepta shares took a record plunge in November, when the company said that the FDA considered its plans to file for approval based on existing data premature. The communication followed a failed late-stage clinical study of a competitor drug called drisapersen, being developed by Prosensa and GlaxoSmithKline. Glaxo has since ended the partnership.
Sarepta shares were trading up 50 percent in early trading. (Track Sarepta shares here.)