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 newspaper.
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 said.
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.