Sarepta Stock Nearly Doubles On FDA Approval For DMD Drug
Zacks Investment Research | Sep 19, 2016 10:13PM ET
Shares of Sarepta Therapeutics, Inc. (NASDAQ:SRPT) shot up 73.9% on Monday after the company announced that it has received accelerated approval for its Duchenne muscular dystrophy (DMD) drug, Exondys 51 (eteplirsen), in the U.S.
Sarepta’s shares hit a new 52-week high of $56.18 on Monday, after nearly doubling from the Sep 16 closing price and closed a little lower at $48.94. Shares were also up almost 6% during the pre-market trading session on Tuesday.
Exondys 51 (30 mg/kg) has been approved as a once-weekly intravenous infusion, specifically indicated for patients who have a confirmed mutation of the DMD gene amenable to exon 51 skipping.
The approval was based on an increase in dystrophin in skeletal muscles, which was observed in some Exondys 51-treated patients in pivotal studies. However, a clinical benefit of the drug, including improved motor function, could not be established.
The FDA stated that Sarepta needs to conduct a study to evaluate whether the drug improves motor function in DMD patients with a confirmed mutation of the dystrophin gene amenable to exon 51 skipping, to confirm the drug’s clinical benefit. Any failure to do this may lead to the withdrawal of the FDA approval.
Expectations of an FDA approval of the drug were already high last week when one of the chief critics of the drug, Dr. Ron Farkas, left his job at the FDA. We remind investors that in Apr 2016, an FDA advisory committee voted against approving eteplirsen for the treatment of DMD. Dr. Ronald Farkas had led the panel and has reportedly been critical of the drug. Shares had then gained around 27%.
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