Sarepta Therapeutics Inc (NASDAQ:SRPT), a developer of innovative RNA-targeted therapeutics, today announced that the U.S. Food and Drug Administration (FDA) has filed the New Drug Application (NDA) for eteplirsen for the treatment of Duchenne muscular dystrophy (DMD) amenable to exon 51 skipping. Approximately 13% of people with Duchenne muscular dystrophy are estimated to have a mutation addressable by Eteplirsen/exon 51 skipping.
The FDA has completed its filing review and has determined that our application is sufficiently complete to permit a substantive review. The Prescription Drug User Fee Act (PDUFA) action date for a decision on the application is February 26, 2016. The FDA has granted eteplirsen Priority Review status, which is designated to drugs that offer benefit over existing therapies, or provide a treatment where no adequate therapy exists.
“We are pleased with the FDA’s acceptance of our NDA for eteplirsen, as it represents an important milestone, not only for Sarepta, but for the Duchenne community. We look forward to continuing to work closely with the FDA during the regulatory review process,” said Edward M. Kaye, interim chief executive officer and chief medical officer. “We believe eteplirsen has the potential to make a meaningful impact on the lives of patients amenable to skipping exon 51 and we aim to build on our experience with eteplirsen to work with the FDA to inform and potentially expedite the clinical and regulatory pathway for the follow on exons, with the goal of reaching as many patients amenable to exon skipping as possible.” (Original Source)
Shares of Sarepta Therapeutics opened today at $32.58. SRPT has a 1-year high of $36.90 and a 1-year low of $11.33. The stock’s 50-day moving average is $32.71 and its 200-day moving average is $21.98.
On the ratings front, Sarepta Therapeutics has been the subject of a number of recent research reports. In a report released yesterday, Piper Jaffray analyst Edward Tenthoff upgraded SRPT to Buy, with a price target of $48, which implies an upside of 47.3% from current levels. Separately, on August 19, Roth Capital’s Debjit Chattopadhyay reiterated a Buy rating on the stock and has a price target of $45.
According to TipRanks.com, which ranks over 7,500 financial analysts and bloggers to gauge the performance of their past recommendations, Edward Tenthoff and Debjit Chattopadhyay have a total average return of 13.6% and 17.2% respectively. Tenthoff has a success rate of 45.6% and is ranked #415 out of 3730 analysts, while Chattopadhyay has a success rate of 51.9% and is ranked #78.
Overall, 4 research analysts have assigned a Hold rating and 7 research analysts have given a Buy rating to the stock. When considering if perhaps the stock is under or overvalued, the average price target is $35.00 which is 7.4% above where the stock opened today.
Sarepta Therapeutics Inc is a biopharmaceutical company focused on the discovery and development of unique RNA-targeted therapeutics for the treatment of rare, infectious and other diseases.