Edison Investment Research Believes FDA Approval for Sarepta's Eteplirsen Could Come Before Year-End

In a report published Wednesday, Edison Investment Research analyst Jason Zhang, Ph.D. commented on Sarepta Therapeutics' (NASDAQ: SRPT) recent reaction to the FDA's request for additional information on eteplirsen.

In the report, Zhang wrote, "The FDA's request for additional information from the existing eteplirsen database before it can consider an accelerated approval of the DMD drug puts the agency squarely in the middle of the bull and bear scenarios for Sarepta, which was reflected in the modest share price decline post announcement. Sarepta plans to provide the FDA with a “coherent and comprehensive summary to support dystrophin as a surrogate" for clinical efficacy and a “detailed discussion of all clinical outcomes in the eteplirsen study”, upon which the FDA will base its decision on the acceptability of the dataset for an NDA filing, likely before the end of the year."

Shares of Sarepta Therapeutics are trading down 2.20 percent from Tuesday's $30.92 closing price.