REUTERS
In a release on Monday morning, Sarepta announced that the FDA was requiring the company to submit additional data for its planned New Drug Application for the approval of eteplirsen.
Eteplirsen is being tested for the treatment of Duchenne muscular dystrophy, a degenerative neuromuscular disorder that causes severe muscle loss and premature death. The disease affects about 1 in 3,500 boys worldwide.
In its statement, Sarepta said: "The FDA indicated that further discussion with Sarepta 'will be necessary to determine what would constitute a complete NDA.' Based on these requests, Sarepta plans to submit an NDA by mid-year 2015, pending any additional requests from further discussions with the FDA."
In August, Sarepta said it was on track to submit an NDA for eteplirsen by the end of this year.
In a statement Chris Garabedian, president and CEO of Sarepta Therapeutics said: "We are committed to satisfying the FDA's updated requests for these specific data to be included as part of an NDA submission and will continue to work with the Agency toward the goal of a complete and acceptable NDA filing. We believe all of the data requests and additional FDA discussions that have currently been outlined can be completed in time for an NDA submission by mid-year 2015. Obtaining an FDA approval of eteplirsen for the DMD patients who may benefit from the drug continues to be our highest priority."
The negative announcement regarding eteplirsen follows news that Sarepta is working to develop a treatment for Ebola.
That announcement boosted shares earlier this month, but in premarket trade Monday the stock had given up all those gains and then some.