Sarepta Shares Surge on Drug Update
Sarepta Therapeutics, Inc. (MM) (NASDAQ:SRPT)
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Heute : Mittwoch 20 Mai 2015
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Sarepta Therapeutics Inc. said that following a meeting with the U.S. Food and Drug Administration, the company plans to begin this week the process of getting regulatory approval for its treatment of a rare genetic disorder.
Shares of Sarepta surged 34% to $21.90 in after-hours trading as the news suggested an easing in the company's relationship with the regulatory agency. Tension between the two sides contributed to the surprising resignation last month of Sarepta Chief Executive Chris Garabedian.
Sarepta is developing eteplirsen to treat Duchenne muscular dystrophy, a rare condition that destroys muscles and frequently kills patients by their 30s. The disease affects roughly one in every 3,500 boys world-wide.
The Cambridge, Mass., biotechnology company said it plans to file this week a partial submission for approval of eteplirsen and that it would file the second part of its "rolling" application by midyear.
Mr. Garabedian's departure last month came after Sarepta appeared to have angered the FDA with a news release about the approval process for its drug. When asked why Mr. Garabedian departed so abruptly, interim chairman John Hodgson said "it's really about going in a different direction…to ensure we have the best opportunity with the FDA" to receive approval.
Sarepta shares have swung wildly as hopes for the drug—which some believe represents a breakthrough—have risen and fallen. Over the past 12 months, the stock has traded between $19.15 and 35.74.
Write to Maria Armental at maria.armental@wsj.com
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