Sarepta (SRPT) Posts Y/Y Wider Q2 Loss, Eteplirsen In Focus

Sarepta Therapeutics, Inc. (NASDAQ:SRPT) reported a loss of $1.34 per share in the second quarter of 2016, wider than both the Zacks Consensus Estimate of a loss of $1.19 and the year-ago loss of $1.01.

The company did not record any revenue in the reported quarter, as was the case a year ago. The Zacks Consensus Estimate for revenues was $1.10 million.

Other Details

Research and development expenses increased 51.7% year over year to $44.3 million, while general and administrative expenses were up almost 38% to $17.8 million.

Sarepta’s lead candidate, eteplirsen, is currently under review in the U.S. The company is looking to get eteplirsen approved for the treatment of patients suffering from Duchenne muscular dystrophy amenable to exon 51 skipping.

We remind investors that the FDA had failed to provide a decision on the candidate by the extended Prescription Drug User Fee Act (PDUFA) date of May 26, 2016 (previous deadline: Feb 26, 2016). The agency informed the company that it was still reviewing the New Drug Application (NDA) and will try to reach a decision as early as possible.

This June, the FDA requested the company to provide dystrophin data from biopsies obtained from the ongoing confirmatory study on eteplirsen as part of the agency’s ongoing evaluation of the NDA.

Given that Sarepta has no approved product in its portfolio at the moment and that eteplirsen is its lead pipeline candidate, the delay in its approval is weighing on the company’s prospects. Investor focus is expected to remain on the approval status of eteplirsen.

Sarepta is a Zacks Rank #3 (Hold) stock. Some better-ranked stocks in the health care sector include Nektar Therapeutics (NASDAQ:NKTR) , CytRx Corporation (NASDAQ:CYTR) and Innoviva, Inc. (NASDAQ:INVA) . Each of these stock sports a Zacks Rank #1 (Strong Buy).

Want the latest recommendations from Zacks Investment Research? Today, you can download 7 Best Stocks for the Next 30 Days. Click to get this free report >>