Sarepta Therapeutics (NASDAQ: SRPT) reported Q3 EPS of ($0.70), $0.26 better than the analyst estimate of ($0.96). Revenue for the quarter came in at $1.1 million versus the consensus estimate of $3.07 million.

In light of the recent FDA guidance for the eteplirsen NDA, the Company has reduced planned expenditures for the remainder of the year, and now expects non-GAAP loss from operations to range from $110 to $120 million, down from previous guidance of $135 to $145 million. The Company expects that its current financial position and prudent expense management will support the execution of its strategic business plan.

The company said Eteplirsen confirmatory study in ambulatory patients and study in advanced/non-ambulatory patients to begin dosing this month. New Drug Application submission for eteplirsen planned for mid-year 2015 based on recent FDA guidance.

“Our top priority is working as rapidly as possible toward a potential eteplirsen approval, by pursuing a dataset that will satisfy the requirements for an FDA filing and that will stand up to the rigor of the review process,” said Chris Garabedian, President and Chief Executive Officer of Sarepta. “We will soon begin dosing with eteplirsen in our confirmatory study in ambulant patients and our study in more progressed and non-ambulant patients, and we are quickly moving forward with additional studies across our DMD program.”

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