On May 19, Sarepta Therapeutics Inc (NASDAQ: SRPT) announced plans to complete a New Drug Application (NDA) for eteplirsen, Sarepta’s lead product candidate. SRPT shares surged 44% to $23 following the news. Eteplirsen is a treatment for Duchenne muscular dystrophy and Sarepta plans to complete the application by mid-2015.
Sarepta’s interim CEO Edward Kaye, M.D., noted, “The initiation of our NDA submission for eteplirsen marks a significant milestone for the Duchenne community, and we look forward to completing the submission by the middle of the year and to continuing to work with the [FDA] towards the goal of providing treatments to patients as quickly as possible.”
Christopher Garabedian resigned suddenly as Sarepta’s CEO last month. Garabedian’s resignation served as a disruption in conversations with the FDA about eteplirsen.
Several analysts weighed in on the stock following the news. Due to the volatility of SRPT shares in the past two year, most analysts have not earned high success rates or average return recommending this pharmaceutical company.
On May 19, Christopher Marai of Oppenheimer maintained an Outperform rating on Sarepta Therapeutics with a $45 price target, assuming accelerated approval of eteplirsen. Marai noted that the rolling NDA submission “bodes well for NDA-filing” and for “chances for approval.” The analyst also noted the “New CEO previously highlighted that if for any reason FDA signaled submission not ready at pre-NDA meeting, SRPT would not submit.” Marai expects NDA filing by the FDA for accelerated approval of the drug by the third quarter and estimates full approval by 2017.
Christopher Marai has a 77% overall success rate recommending stocks with a +31.8% average return per rating. He has rated SRPT 11 times since April 2013, he has earned a 64% success rate recommending the stock with a 1.7% average loss per SRPT rating.
However, not all analysts were as bullish on the stock. Edward Tenthoff of Piper Jaffray reiterated a Neutral rating on Sarepta Therapetuics with a $20 price target. Tenthoff seemed cautious when noting that “It was not disclosed what, if any, changes to the NDA packet were agreed upon.” He continued, “Dosing has begun in the 48-week, open-label Phase III confirmatory study of eteplirsen in ambulatory DMD boys as well as a 96-week study in 20 non-ambulant DMD boys.”
Edward Tenthoff has a 67% overall success rate recommending stocks with a +28.9% average return per rating. Tenthoff has rated SRPT eight times since April 2013, earning a 50% success rate recommending the stock with a 26.6% average loss per rating.
Separately, Adam Walsh of Canaccord Genuity upgraded SRPT from Neutral to Buy and raised his price target from $14 to $33. Walsh has a 78% overall success rate recommending stocks with a +32.5% average return per rating. Since he has only rated SRPT with a Neutral rating once before, he does not have a success rate or average return recommending the stock.
While analysts have not fared well recommending SRPT in particular, they have earned tremendous returns recommending other biotech stocks. Check out their performance history to see where they earned the greatest returns.
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