Sarepta Therapeutics Inc (NASDAQ:SRPT), a developer of innovative RNA-targeted therapeutics, announced that the Peripheral and Central Nervous System Drugs Advisory Committee of the U.S. Foodand Drug Administration (FDA) will review Sarepta’s New Drug Application (NDA) for eteplirsen, on January 22, 2016. The Prescription Drug User Fee Act (PDUFA) action date for completion ofFDA review of the eteplirsen NDA is February 26, 2016.
It is estimated that DMD 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.
“Duchenne muscular dystrophy is a devastating disease with no currently approved treatment available to the patients and families it affects.” said Edward Kaye, M.D., Sarepta’s interim chief executive officer and chief medical officer. “We look forward to discussing the efficacy and safety data included in our NDA submission for eteplirsen with the Advisory Committee, with the ultimate goal of bringing a treatment to patients with Duchenne amenable to skipping exon 51.”
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. (Original Source)
Shares of Sarepta Therapeutics closed yesterday at $35.83, down $1.37 or -3.68%. SRPT has a 1-year high of $41.97 and a 1-year low of $11.33. The stock’s 50-day moving average is $31.51 and its 200-day moving average is $32.14.
On the ratings front, Sarepta has been the subject of a number of recent research reports. In a report issued on November 25, Needham analyst Chad Messer reiterated a Buy rating on SRPT, with a price target of $55, which implies an upside of 53.5% from current levels. Separately, on the same day, Jefferies Co.’s Gena Wang maintained a Hold rating on the stock and has a price target of $38.
According to TipRanks.com, which ranks over 7,500 financial analysts and bloggers to gauge the performance of their past recommendations, Chad Messer and Gena Wang have a total average return of -4.7% and -15.5% respectively. Messer has a success rate of 32.6% and is ranked #3286 out of 3643 analysts, while Wang has a success rate of 44.4% and is ranked #3235.
The street is mostly Bullish on SRPT stock. Out of 12 analysts who cover the stock, 10 suggest a Buy rating and 2 recommend to Hold the stock. The 12-month average price target assigned to the stock is $41.00, which represents a potential upside of 14.4% from where the stock is currently trading.
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.