Sarepta Therapeutics Inc (NASDAQ:SRPT), a developer of innovative RNA-targeted therapeutics, today announced that the Peripheral and Central Nervous System (PCNS) Drugs Advisory Committee of the U.S. Food and Drug Administration (FDA) will review Sarepta’s New Drug Application (NDA) for eteplirsen on April 25, 2016. The Prescription Drug User Fee Act (PDUFA) action date for completion of FDA review of the eteplirsen is May 26, 2016.
The FDA has granted eteplirsen Priority Review status, which is designated for drugs which provide a treatment where no adequate therapy exists. The FDA also granted Rare Pediatric Disease Designation to eteplirsen, as well Orphan Drug Designation and Fast Track Status.
It is estimated that Duchenne muscular dystrophy affects approximately one in every 3,500 – 5,000 boys born worldwide, with 13% of people with the disease having mutations addressable by eteplirsen/exon 51 skipping.(Original Source)
Shares of Sarepta Therapeutics closed last Friday at $15.74, down $0.17 or -1.07%. SRPT has a 1-year high of $41.97 and a 1-year low of $10.20. The stock’s 50-day moving average is $13.17 and its 200-day moving average is $27.73.
On the ratings front, Sarepta has been the subject of a number of recent research reports. In a report issued on March 10, Piper Jaffray analyst Edward Tenthoff maintained a Hold rating on SRPT, with a price target of $15, which represents a slight downside potential from current levels. Separately, on February 26, Cowen’s Ritu Baral reiterated a Hold rating on the stock .
According to TipRanks.com, which ranks over 7,500 financial analysts and bloggers to gauge the performance of their past recommendations, Edward Tenthoff and Ritu Baral have a total average return of -9.1% and 3.9% respectively. Tenthoff has a success rate of 29.8% and is ranked #3572 out of 3724 analysts, while Baral has a success rate of 37.5% and is ranked #670.
Overall, 4 research analysts have assigned a Hold rating and 3 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 $45.00 which is 185.9% above where the stock closed last Friday.
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.