Company Update (NASDAQ:SRPT): Sarepta Therapeutics Inc Announces EMA Validation of Eteplirsen Authorization Application for Treatment of Duchenne Muscular Dystrophy

Sarepta Therapeutics Inc (NASDAQ:SRPT) announced that the European Medicines Agency (EMA) validated the previously submitted Marketing Authorization application (MAA) for eteplirsen to treat Duchenne muscular dystrophy amenable to exon 51 skipping. Sarepta is seeking conditional approval of eteplirsen in the EU through the centralized procedure. Validation of the MAA confirms that the submission is accepted and starts the formal review process by the EMA’s Committee for Human Medicinal Products (CHMP). The standard review period is 210 days (plus additional time for applicant to respond to questions from the agency).

“Around the world, there are many patients living with DMD who do not have access to a medicine that treats the underlying cause of the disease,” said Edward Kaye, Sarepta’s chief executive officer. “The validation of the MAA is the next step toward our goal of providing potential therapies to more patients with Duchenne in Europe.” (Original Source)

Shares of Sarepta Therapeutics are currently rising 1.37% to $30.40, or up $0.41 in after-market trading Monday. SRPT has a 1-year high of $63.73 and a 1-year low of $8. The stock’s 50-day moving average is $36.05 and its 200-day moving average is $32.97.

On the ratings front, Sarepta Therapeutics has been the subject of a number of recent research reports. In a report issued on December 16, RBC analyst Simos Simeonidis reiterated a Buy rating on SRPT, with a price target of $98, which represents a potential upside of 227% from where the stock is currently trading. Separately, on December 14, Jefferies Co.’s Gena Wang reiterated a Hold rating on the stock and has a price target of $32.

According to, which ranks over 7,500 financial analysts and bloggers to gauge the performance of their past recommendations, Simos Simeonidis and Gena Wang have a yearly average loss of -26.5% and -7.7% respectively. Simeonidis has a success rate of 27% and is ranked #4183 out of 4283 analysts, while Wang has a success rate of 38% and is ranked #4039.

Sentiment on the street is mostly bullish on SRPT stock. Out of 13 analysts who cover the stock, 10 suggest a Buy rating and 3 recommend to Hold the stock. The 12-month average price target assigned to the stock is $69.50, which implies an upside of 132% from current levels.

Sarepta Therapeutics, Inc. is a biopharmaceutical company, which is engaged in the discovery and development of unique RNA-based therapeutics for the treatment of rare and infectious diseases. The company is primarily focused on rapidly advancing the development of its potentially disease modifying duchenne muscular dystrophy drug candidates. 

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