Sarepta Therapeutics Inc (NASDAQ:SRPT) shares shot up nearly 13% today in the wake of Dr. Ronald Farkas, arguably the most oppositional team leader of the review board to the approval of Duchenne Muscular Dystrophy (DMD)-treating pipeline drug eteplirsen, has officially left the FDA.
In reaction, Oppenheimer analyst Michelle Gilson reiterates an Outperform rating on SRPT with a price target of $60, which represents a 134% increase from where the shares last closed.
Gilson notes that both the DMD community and experts alike “were particularly inflamed” back in May’s advisory committee for eteplirsen, when Dr. Farkas led the review, as remarks pertaining to patient effort amid the trial coupled with the way the review board treated the data were taken out of the context from a rare disease setting.
Gilson adds, “Contrarily, we would have viewed a promotion for Farkas or departure of a more supportive figure (i.e., Woodcock) as a negative signal for eteplirsen approval. We continue to believe that eteplirsen will be approved, and a label will be based on dystrophin production at 48-weeks across the two trials, supported by 6MWT trends.”
To Gilson, this departure shines light on a potential forthcoming decision, as she does not surmise Dr. Farkas would simply leave “voluntarily” if the FDA had not arrived at a final conclusion as far as reviewing eteplirsen for approval. In fact, she predicts the decision has already been made and believes the FDA is past the point of reviewing data.
“We believe the FDA will notify the company and the public of its decision very soon. Label negotiations may still be in progress. We continue to anticipate accelerated approval,” the analyst concludes.
According to TipRanks, which measures analysts’ and bloggers’ success rate based on how their calls perform, four-star analyst Michelle Gilson is ranked #940 out of 4,163 analysts. Gilson has a 50% success rate and realizes 15.6% in her annual returns. When recommending SRPT, Gilson earns 59.1% in average profits on the stock.
TipRanks analytics exhibit SRPT as a Hold. Based on 13 analysts polled in the last 3 months, 4 rate a Buy on SRPT, 5 maintain a Hold, while 4 issue a Sell. The consensus price target stands at $16.30, marking a 36% downside from where the stock is currently trading.