NEW YORK, March 24 Shares of Sarepta
Therapeutics could rise swiftly and hit $50 a share if
it seeks accelerated approval from the U.S. Food and Drug
Administration for eteplirsen, a drug being tested for Duchenne
muscular dystrophy, according to a report in Barron's financial
The drug could generate $500 million in yearly revenue just
in the United States, the report in the March 25 edition of the
weekly newspaper said. If the company seeks accelerated
approval, it could indicate favorable FDA feedback, the report
Barron's said that the company was scheduled to meet with
the FDA this month to review the clinical data and by late April
should have guidance from the agency on whether or not it is
amenable to accelerated approval or whether it will require a
full Phase 3 trial.
Favorable results from Phase 2B clinical trials have already
driven the stock up in the past year, the report said.
Failure to seek accelerated approval would delay the drug's
potential approval and could suggest the FDA has concerns. That
could cause the shares, which closed at $32.77 on Friday, to
decline into the $20s.