Sarepta Therapeutics Inc (NASDAQ:SRPT), a developer of innovative RNA-targeted therapeutics, announced that the Company held a pre-New Drug Application (NDA) meeting with the U.S. Food and Drug Administration (FDA) regarding its lead product candidate, eteplirsen, for the treatment of Duchenne muscular dystrophy (DMD). Sarepta has agreed with the Agency to initiate a rolling NDA submission and will submit the non-clinical and CMC components of the NDA by the end of this week. As previously announced, Sarepta plans to submit the final component of the NDA by mid-year 2015.
“We will initiate a rolling NDA submission to facilitate the regulatory review of the NDA,” saidEdward Kaye, M.D., Sarepta’s interim chief executive officer and chief medical officer. “The initiation of our NDA submission for eteplirsen marks a significant milestone for the Duchenne community and we look forward to completing the submission by the middle of the year and to continuing to work with the Agency towards the goal of providing treatments to patients as quickly as possible.” (Original Source)
Shares of Sarepta Therapeutics closed today at $16.40, $0.47 or 2.95%. SRPT has a 1-year high of $35.45 and a 1-year low of $11.33. The stock’s 50-day moving average is $13.98 and its 200-day moving average is $14.05.
On the ratings front, Sarepta has been the subject of a number of recent research reports. In a report issued on May 7, Needham analyst Chad Messer reiterated a Buy rating on SRPT. Separately, on May 6, Robert W. Baird’s Brian Skorney upgraded the stock to Buy and has a price target of $20.
According to TipRanks.com, which ranks over 7,500 financial analysts and bloggers to gauge the performance of their past recommendations, Chad Messer and Brian Skorney have a total average return of -1.5% and 19.0% respectively. Messer has a success rate of 36.5% and is ranked #3046 out of 3606 analysts, while Skorney has a success rate of 69.0% and is ranked #191.
The street is mostly Bullish on SRPT stock. Out of 7 analysts who cover the stock, 5 suggest a Buy rating and 2 recommend to Hold the stock. The 12-month average price target assigned to the stock is $27.80, which represents a potential upside of 71.8% 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.