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Sarepta Therapeutics: FDA Considers NDA Filing for Eteplirsen "Premature"

Sarepta Therapeutics: FDA Considers NDA Filing for Eteplirsen "Premature"
Sarepta Says FDA Postpones Advisory Committee Meeting to Review Eteplirsen Due to Severe Weather Storm in the Washington D.C.

Shares of Sarepta Therapeutics (NASDAQ: SRPT) tumbled more than 50 percent on Tuesday, 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 Administration 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 low of $14.90.

Posted-In: Chris Garabedian CNBC Jim CramerCNBC News Jim Cramer FDA Media Best of Benzinga


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