Sarepta Therapeutics Inc (NASDAQ:SRPT) Shares to Retreat on FDA Review Delay?


Sarepta Therapeutics Inc (NASDAQ:SRPT) shares rose 26.63% on Tuesday to $23.10, returning 1.07% to $23.10 in after-hours trading.

Sarepta Therapeutics Inc (NASDAQ:SRPT) shared that the U.S. Food and Drug Administration (FDA) notified the company that it will not be able to complete their work by the Prescription Drug User Fee Act (PDUFA) target date of May 26, 2016. The FDA will continue their review and internal discussions regarding the pending NDA for eteplirsen, an RNA-based therapeutic drug designed treatment of some mutations that cause the genetic degenerative muscle disease Duchenne muscular dystrophy (DMD).

Still, the FDA has reiterated that they will continue to work past the PDUFA goal date and strive to complete their work in as timely a manner as possible. Eteplirsen is an antisense phosphorodiamidate morpholino oligomer (PMO) therapeutic in Phase III clinical development for the treatment of individuals with DMD having an error in the gene coding for dystrophin that is amenable to skipping exon 51.

Earlier this month, shares of Sarepta Therapeutics Inc (NASDAQ:SRPT) surged when the company announced that it is anticipating accelerated approval for eteplirsen. Keep in mind that Sarepta suffered a downgrade from analysts after an FDA panel rejected its DMD drug last month, when seven committee members maintained that there wasn’t any sufficient evidence of the drug’s effectiveness.

Sarepta Therapeutics Inc (NASDAQ:SRPT) is a biopharmaceutical company that focuses on the discovery and development of RNA-based therapeutics for the treatment of rare, infectious and other diseases. It operates on its own behalf or in collaboration with other companies in similar fields. Through its platform technologies, the company works on targeting a range of diseases and disorders through RNA-targeted mechanisms of action.


DISCLAIMER: There is a substantial risk of loss with any speculative asset, especially small cap stocks. The opinions expressed are those of the author, and do not constitute recommendations to buy or sell a stock. Do your own research before committing capital.