Sarepta Up 12% As FDA Is 'Actively Engaged' On Drug Application

Sarepta Therapeutics SRPT opened sharply higher after the Food and Drug Administration made favorable noises about the company's plan to seek clearance for its treatment of Duchenne muscular dystrophy.

Sarepta expects to file a New Drug Application for its lead drug, called eteplirsen, later this year and also begin several clinical trials. Sarepta has no products approved for marketing.

Responding to an electronic petition with more than 100,000 signatures, the FDA's drug evaluation director Janet Woodcock said the agency is "actively engaged with a number of drug companies focused on developing new drugs for Duchenne," including Sarepta.

In her response, Woodcock noted Sarepta's application plan and said her agency is "willing to explore the use of all potential pathways for the approval of drugs for Duchenne muscular dystrophy including accelerated approval."

The petition, to the Obama Administration's electronic petition website called We the People, urged accelerated approval for treatment of Duchenne muscular dystrophy, which it called "the leading genetic killer of children that impacts one out of every 3,500 boys born in the U.S."

Sarepta last week dismissed its chief scientist Arthur Krieg, reportedly after Krieg raised management concerns with its board.

There are currently no FDA-approved therapies for the disease.

Sarepta traded recently at $22.96, up 12.9 percent.