Sarepta Therapeutics Inc. surged as much as 20% in pre-market trade Thursday, after a media report suggested the biotechnology company can still secure approval for its muscular dystrophy treatment despite a negative panel vote. The report, titled "How Sarepta Can Secure Speedy FDA Drug Approval Despite a Negative Panel Vote, by TheStreet.com's Adam Feurstein came on the heels of a Food and Drug Administration committee's Monday vote against recommending Sarepta's Duchenne muscular dystrophy drug, eteplirsen, for accelerated drug approval and against the drug's effectiveness. Feuerstein pointed out supportive statements made by the FDA's Dr. Janet Woodcock, as well as the official's meeting with patients and their families after the panel. Meanwhile, WBB Securities LLC President Steve Brozak reiterated his company's "strong buy" recommendation and a 12-month price target of $40 in a note Tuesday, saying the mixed nature of the panel's vote "reflects what the FDA calls a Type Two Mistake - failure to approve a beneficial drug." Brozak also cited Woodcock's words encouraging panel members to consider the data in whole, saying "we believe there is a good chance the FDA will ultimately grant conditional approval to eteplirsen and demand a post-approval trial by Sarepta Therapeutics, Inc."
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