Sarepta's Eteplirsen Receives Accelerated FDA Approval, Shares Soar 80%
Shares of Sarepta Therapeutics Inc (NASDAQ: SRPT) soared more than 80 percent Monday morning after the U.S. Food and Drug Administration confirmed in a letter it granted the company with an accelerated approval for its Eteplirsen drug.
Sarepta's drug is intended for the treatment of Duchenne Muscular Dystrophy (DMD) in patients who have a confirmed mutation of the DMD gene.
"We have completed our review of this application, as amended," the FDA said in its letter. "It is approved under the provisions of accelerated approval regulations (21 CFR 314.500), effective on the date of this letter, for use as recommended in the enclosed agreed-upon labeling text."
Sarepta's stock hit a 52-week low of $8 in late April following an FDA hearing in which the agency said the drug won't receive approval for the treatment of Duchenne muscular dystrophy at that time.
"Although FDA is prepared to be flexible with respect to a devastating illness with no treatment options, we cannot approve drugs for which substantial evidence of effectiveness has not been established," the FDA said in its document in late April.
Shares of Sarepta rose more than 20 percent on September 14 after Benzinga reported Dr. Ron Farkas, an FDA official who opposed Sarepta's drug, left the agency.
Shares of Sarepta hit a new 52-week high of $52.30 on Monday following the announcement. It traded recently at $48.14, up 71 percent.
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