How Sarepta Therapeutics Inc (NASDAQ:SRPT) Shares Are Reacting to Its FDA Request


Sarepta Therapeutics Inc (NASDAQ:SRPT) shares rose to $19.67 as of the market close on Tuesday but retreated by 0.10% to $19.65 in after hours trading. The company recently got a request from the FDA for dystrophin data before making a decision on the eteplirsen NDA.

A few months back, Sarpeta Therapeutics shares surged on expectations of an accelerated approval for eteplirsen. This is an RNA-based therapeutic drug designed treatment of some mutations that cause the genetic degenerative muscle disease Duchenne muscular dystrophy (DMD). However, the stock returned most of its gains on news of an FDA delay, as the agency 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.

For now, the FDA is carrying on with its discussions on the pending NDA for eteplirsen and that they will continue to work past the PDUFA goal date and strive to complete their work in as timely a manner as possible. An update revealed that the company plans to submit data from thirteen patient biopsy samples, at baseline and week 48, to the FDA over the next few weeks.

These updates led analysts at Wedbush to upgrade their assessment for Sarepta Therapeutics shares from Neutral to Outperform, nearly doubling their price target from $14 to $36 in anticipation that the FDA review is proceeding well and might yield good results for the company.

Sarepta Therapeutics is a biotech company focused on the discovery and development of ribonucleic acid (RNA)-targeted therapeutics for the treatment of rare, infectious and other diseases. Through its platform technologies, the company works on targeting a range of diseases and disorders through RNA-targeted mechanisms of action. It operates on its own behalf or in collaboration with other companies in similar fields.


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