Leerink affirms Sarepta (Nasdaq: SRPT) at Underperform with a price target of $5 after the company announced that the U.S. Food and Drug Administration (FDA) has requested that Sarepta provide dystrophin data, as measured by western blot, from biopsies already obtained from the ongoing confirmatory study of eteplirsen (PROMOVI), as part of its ongoing evaluation of the eteplirsen New Drug Application (NDA).

Analyst Joseph P. Schwartz commented, [Sarepta's] PR disclosing the imminent submission of biopsy samples (n=13; baseline and week 48) re-ignited optimism for eteplirsen. In light of the FDA/AdCom's lack of enthusiasm for previous dystrophin data, its lack of correlation with functional outcomes, and numerous other questionable factors, we detail four reasons to remain cautious. Although the market's initial knee-jerk reaction is positive (~25%+ in after-hours), with today's disclosure providing minimal detail suggesting a change in course is likely we are reiterating our UP rating on SRPT.

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Analyst Comments FDA

Piper Jaffray Remains Negative on Sarepta (SRPT), 'Unable to Handicap Chances for AA'June 7, 2016 9:08 AM Jefferies Continues to See Low Probablity of Sarepta (SRPT) ApprovalJune 7, 2016 7:50 AM Sarepta (SRPT): Accelerated Approval Seen Pending Dystrophin Data Analysis - OppenheimerJune 7, 2016 6:49 AM Wedbush Upgrades Sarepta Therapeutic (SRPT) to Outperform, $36 PTJune 7, 2016 6:40 AM Sarepta (SPRT): FDA Request for Dystrophin Data a 'Clear Indication Willing to Grant Accelerated Approval' - BairdJune 7, 2016 6:25 AM Sarepta Therapeutics (SRPT) Surges as FDA Requests Dystrophin Data for eteplirsen NDAJune 6, 2016 5:45 PM Sarepta Therapeutics (SRPT) Says FDA Requests Dystrophin DataJune 6, 2016 5:41 PM Sarepta Therapeutics Announces FDA Request For Dystrophin Data Prior To Making A Decision on Eteplirsen NDAJune 6, 2016 5:40 PM