Roth Capital Remains Positive On Sarepta Following NDA Submission Delay

In a research report issued today, Roth Capital analyst Debjit Chattopadhyay maintained a Buy rating on Sarepta Therapeutics Inc. (NASDAQ:SRPT) with a $22 price target, following the news that additional data are required as part of Sarepta’s New Drug Application (NDA) submission for the approval of eteplirsen for the treatment of Duchenne muscular dystrophy.

Chattopadhyay wrote, “The FDA wants three months’ data from at least 12 to 24 newly exposed patients at the time of NDA submission. Additionally, the FDA also wants all available data from the other patients enrolled in the new eteplirsen studies, (301, 203 and 204), even if exposure is less than three months. Sarepta intends to begin enrollment during November 2014, and 15 plus patients can be enrolled in about three months, in our view. Since the planned pivotal study is an open label, this request from the FDA can be addressed by mid-2015.”

The analyst continued, “The FDA strongly advises Sarepta to obtain and submit patient level natural history data: This adds significant uncertainties because: (1) SRPT does not have access to individual patient data from independent studies performed at multiple institutions. (2) SRPT has compared its data to aggregate or mean six-minute walk test from natural history studies. The FDA wants to compare treatment benefits on an individual (potentially age matched) level, which could get tricky. The request for exploratory MRI data from an NIH sponsored study is baffling because this was not a part of the original eteplirsen study.”

According to, which measures analysts’ and bloggers’ success rate based on how their calls perform, analyst Debjit Chattopadhyay has a total average return of -14.0% and a 33.3% success rate. Chattopadhyay has a -30.1% average return when recommending SRPT, and is ranked #3310 out of 3349 analysts.

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