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Sarepta Falls on Investor Skepticism of Approval Plans

Sarepta Therapeutics Inc. plummeted the most in 15 months on investor concerns that U.S. regulators won’t consider the company’s treatment for Duchenne muscular dystrophy on an accelerated basis.

Sarepta, with no products on the market, fell 19 percent to $37.68 at the close of trade in New York, its biggest drop since April 2012. At least three analysts cut their rating on the Cambridge, Massachusetts-based company’s shares, which have risen 46 percent this year.

The biotechnology company announced today it plans to seek approval of eteplirsen in the first half of 2014 after the Food and Drug Administration said it was open to a filing based on data from existing studies. The agency requested information on methodology and verification that will be incorporated into the filing, the company said in a statement. Regulators didn’t commit to considering approval of the compound on an accelerated approval basis, Sarepta said.

“If you’re a bear, you believe that the FDA is just saying ’file,’ and the management is filing just because they can, not because they think they’re going to get approved,” Robyn Karnauskas, a New York-based analyst at Deutsche Bank AG, said in a telephone interview. She reduced her rating on Sarepta to hold from buy.

Sarepta’s stock began falling while Chief Executive Officer Christopher Garabedian talked about the company’s plans on a conference call this morning.

“If he had just said ’we’re filing,’ it would have been up,” Karnauskas said. “But he added some color about what the FDA said, and that color was not enough to encourage the bulls.”

Duchenne muscular dystrophy is a form of the disease that affects boys and worsens quickly. It is caused by a defective gene for a protein in the muscles and occurs in about one of every 3,600 male infants, according to the National Institutes of Health.

Eteplirsen, the developmental drug, manipulates RNA to repair a gene mutation in about 13 percent of patients. If successful, the drug helps the patients produce the missing protein and gain strength.

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