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Sarepta Therapeutics Plummets 50% as FDA Rejects BioMarin's NDA For Duchenne Muscular Dystrophy

Sarepta Therapeutics ( SRPT ) shares were down 50% in recent pre-market trade, extending Thursday’s declines in the wake of the U.S. Food and Drug Administration’s rejection of rival BioMarin Pharmaceutical’s ( BMRN ) new drug application for the treatment of Duchenne muscular dystrophy.

SRPT is trading near the lower end of the 52-week range between $11.42 and $41.97.

In December, Sarepta said the FDA would review its NDA for Eteplirsen to treat DMD. The review will start on Jan. 22 and is expected to be completed by Feb 26, Sarepta said.

Eteplirsen has FDA priority review status as well as rare pediatric disease designation, orphan drug designation and fast track status.

The FDA said BioMarin’s application is not ready for approval in its current firm, concluding that the standard of substantial evidence has not been met.

BMRN was down nearly 2% in recent pre-market trade, near the lower end of its 52-week range between $77.59 and $151.75.

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Sarepta Therapeutics Plummets 50% as FDA Rejects BioMarin's NDA For Duchenne Muscular Dystrophy Reviewed by on . Sarepta Therapeutics ( SRPT ) shares were down 50% in recent pre-market trade, extending Thursday's declines in the wake of the U.S. Food and Drug Administratio Sarepta Therapeutics ( SRPT ) shares were down 50% in recent pre-market trade, extending Thursday's declines in the wake of the U.S. Food and Drug Administratio Rating:
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