Sarepta Crashes 50% Amid Efficacy Concern Related To Eteplirsen

Shares of Sarepta Therapeutics Inc (NASDAQ: SRPT) plunged lower by more than 50 percent ahead of Friday's market open after the FDA released a briefing document related to the company's Eteplirsen.

Sarepta Therapeutics is seeking accelerated approval for eteplirsen for patients with DMD who have a confirmed mutation of the dystrophin gene.

According to the FDA's document, the data provided by Sarepta Therapeutics did not provide statistical evidence to support the efficacy of eteplirsen.

"Although FDA is prepared to be flexible with respect to a devastating illness with no treatment options, we cannot approve drugs for which substantial evidence of effectiveness has not been established," the FDA concluded in its document. "It is important to recognize that no final conclusions have been reached on the approvability of this application, and we look forward to a fruitful discussion of these issues at the Advisory Committee Meeting on January 22, 2016."

Shares traded recently at $15.16, down 52 percent.