Sarepta Therapeutics Announces FDA Considers NDA Filing for Eteplirsen Premature, shares down 50+% - Sarepta Therapeutics (NASDAQ:SRPT)

Shares of

Sarepta TherapueticsSRPT

tumbled more than 50 percent on Tuesday November 12, its worst decline in 16 years. The U.S. regulators questioned the company's trial results for its experimental treatment for Duchenne muscular dystrophy or DMD. The drug called Eteplirsen, or AVI-4658 would be the first approved therapy for the treatment of the genetic degenerative muscle disease. The average life expectancy for patients afflicted with the disease is around 25. The Food and Drug Adminstration called the company's application to sell eteplirsen “premature.” Chris Garabedian, the company's CEO said in a

statement “We strongly believe in the potential of eteplirsen to address a serious unmet medical need in DMD and we are committed to its development.” Shares have been downgraded to Underweight from Overweight at Piper Jaffray with a price target of $20, lowered from $58.

CNBC's Jim Cramer

described the company as a “one trick pony” and owning shares is akin to playing “Russian roulette.” Shares of Sarepta were trading down by as much as 60 percent during the Tuesday morning trading session hitting a new 52 week lows of $14.90.

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