
US FDA sets April 25 date to review Sarepta’s DMD drug, shares jump
pharmafile | March 11, 2016 | News story | Medical Communications, Research and Development | Duchenne Muscular Dystrophy, Eteplirsen, Sarepta Therapeutics, US FDA
Shares in US-based Sarepta Therapeutics (Nasdaq: SRPT) jumped nearly 15% Thursday after the US Food and Drug Administration (FDA) said it will review the company’s trial drug to treat muscle disease on April 25.
Sarepta’s drug candidate Eteplirsen is in clinical trials for the treatment of Duchenne muscular dystrophy (DMD). The meeting was originally scheduled for January 22.
Earlier this week the company announced this year it will close its Oregon facility, which is primarily focused on early-stage research and research manufacturing. The company said, as part of the consolidation, some employees will transition to Sarepta facilities inAndover and Cambridge, Massachusetts.
Edward Kaye, Sarepta’s interim chief executive and chief medical officer, said: “For a biotechnology company of our size and stage of development, it is operationally important to centralize our facilities and focus our efforts on the R&D, manufacturing, and pre-commercialization of eteplirsen. To that end, we will consolidate operations to Massachusetts over the coming year to optimize the efficiency of our R&D and manufacturing teams.”
The PDUFA date for Eteplirsen is May 26, 2016.
Shares in the company closed up 14.7% at $15.91 on the Nasdaq.
Anjali Shukla
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