Sarepta Therapeutics Inc (NASDAQ:SRPT), a developer of innovative RNA-targeted therapeutics, announced the Peripheral and Central Nervous System Drugs Advisory Committee of the U.S. Food and Drug Administration (FDA) is tentatively scheduled to review Sarepta’s New Drug Application (NDA) for eteplirsen, for the treatment of Duchenne muscular dystrophy (DMD) amenable to exon 51 skipping, on January 22, 2016. There has been no formal communication to the company or Federal Register notice of a confirmed advisory committee meeting date.
It is estimated that DMD affects approximately one in every 3,500 boys born worldwide, with 13% of people with the disease having mutations addressable by eteplirsen/exon 51 skipping.
“We have been verbally informed by the FDA that we have a tentative date of January 22, 2016for our advisory committee review of eteplirsen and our PDUFA date of February 26, 2016, remains unchanged.” 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 committee, with the ultimate goal of bringing treatment to more patients with Duchenne.” (Original Source)
Shares of Sarepta Therapeutics Inc. opened today at $32.55 and are currently trading down at $30.03. 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 $36.38 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 October 2, Wedbush analyst Heather Behanna upgraded SRPT to Buy, with a price target of $56, which represents a potential upside of 72.0% from where the stock is currently trading. Separately, on October 1, Piper Jaffray’s Edward Tenthoff maintained a Buy rating on the stock and has a price target of $48.
According to TipRanks.com, which ranks over 7,500 financial analysts and bloggers to gauge the performance of their past recommendations, Heather Behanna and Edward Tenthoff have a total average return of 12.1% and 8.6% respectively. Behanna has a success rate of 50.0% and is ranked #863 out of 3773 analysts, while Tenthoff has a success rate of 40.0% and is ranked #718.
Overall, one research analyst has assigned a Hold rating and 9 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 $47.67 which is 46.5% 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.