Own Shares Of Sarepta Heading Into Friday's FDA Panel On Eteplirsen

• Oppenheimer analysts Christopher Marai and Michelle Gilson reiterated an Outperform rating and $45.00 price target on shares of Sarepta Therapeutics Inc SRPT.

Last Friday, Sarepta published some briefing documents that included an addendum with follow-up data for eteplirsen (EXONDYS 51), the company’s clarifications of FDA briefing document comments, and comparable approvals. Below is a look into what analysts at Oppenheimer think of the “surprise” briefing documents.

According to a report issued Wednesday, Sarepta’s addendum “included new data, at four-years follow-up of patients treated with eteplirsen, highlighting ten patients continue to ambulate, and new analysis on the hard endpoint loss of ambulation (LOA).” The firm’s own analysis of the LOA suggests that the drug may substantially prolong ambulation at four years, even taking into account the best performing historical control cohorts.

Related Link: Sarepta Crashes 50% Amid Efficacy Concern Related To Eteplirsen

The experts noted that Sarepta’s NDA is “forging new regulatory ground, increasing risk to an accelerated approval.” However, at current levels they think the stock is pricing in a “very low chance of approval.” Consequently, the firm’s $45 price target still assumes conditional approval.

Disclosure: Javier Hasse holds no positions in any of the securities mentioned above.