Sarepta Therapeutics Inc (NASDAQ:SRPT) shares are celebrating a 30% rise after the FDA posted negative briefing documents on drisapersen, a DMD medicine produced by its primary rival BioMarin Pharmaceutical Inc. (NASDAQ:BMRN). In the briefing documents, the FDA expressed concern that substantial evidence of clinical efficacy has not been established.
Wedbush analyst Liana Moussatos commented, “In our view, the focus on dystrophin in the briefing documents (and lack of dystrophin production for drisapersen) is a good sign for Sarepta, as the agency appears to be focused on biomarkers for accelerated approval as is the risk/reward for eteplirsen considering its benign profile to date. In our view, the adherence to FDA guidance with regard to natural history controls and confirmatory studies is a plus for Sarepta. We believe approval of eteplirsen is not a slam dunk at this time; however, we see the overall prospects as positive for Sarepta’s approach and its panel in January.”
Cowen analyst Ritu Baral also noted, “First blush analysis of the drisa panel briefing documents is more positive for SRPT than we had anticipated. Remarkably, the FDA spends considerable time discussing BMRN’s thin dystrophin dataset. We view SRPT’s dystrophin dataset as more supportive. Criticism of the small magnitude of post-hoc analysis improvement and directionally worse efficacy signals bodes well for PTCT’s ataluren review.”
According to TipRanks.com, which ranks over 7,500 financial analysts and bloggers to gauge the performance of their past recommendations, Liana Moussatos and Ritu Baral have a yearly average return of 19.2% and 17.6% respectively. Moussatos has a success rate of 42.4% and is ranked #81 out of 3857 analysts, while Baral has a success rate of 46.4% and is ranked #96.
Out of the 10 analysts polled by TipRanks in the last 3 months, 8 rate Sarepta stock a Buy, while 1 rates the stock a Hold and 1 recommends a Sell. With a return potential of 2.67%, the stock’s consensus target price stands at $33.60.