Sarepta Therapeutics Inc., a drug developer with no products on the market, rose to its highest value in five months after saying it plans to submit its Duchenne muscular dystrophy treatment for approval this year.
Sarepta increased 39 percent to $33.98 at 4 p.m. New York time, its highest closing price since Nov. 11.
On Nov. 12, Sarepta shares fell the most in 16 years after the Food and Drug Administration had called an application to sell the experimental eteplirsen compound “premature.” The FDA has provided new guidance that will enable the submission of the drug by the end of 2014, the Cambridge, Massachusetts-based company said today in a statement.
“We are excited to have guidance from the FDA that allows us to move quickly,”said Edward Kaye, chief medical officer at Sarepta.
Sarepta anticipates the FDA may call advisers to discuss eteplirsen in the first half of 2015 and approve the drug by the second half of next year, Robyn Karnauskas, an analyst at Deutsche Bank AG, said in a note to clients today.
Duchenne muscular dystrophy is a genetic disorder that mainly affects boys between ages three and five that causes progressive muscle degeneration and weakness, according to the Muscular Dystrophy Association.
Sarepta will rely on data from an existing phase II study out of three phases typically required for approval. Sarepta is working with the FDA to help the agency gain better understanding of a measurement of a protein responsible for muscle movement the study relies on to provide a reasonable assumption of the drug’s benefit, Sarepta said.
The company will also initiate two studies to confirm the drug’s benefit that will provide early data for eteplirsen’s application and provide further evidence the medicine works once it’s on the market, according to the statement. Sarepta will also begin additional trials in younger and more advanced patients this year.