Shares of drug researcher Sarepta Therapeutics SRPT are down nearly 35% in morning trading Tuesday after an FDA advisory committee announced that it would not recommend the company’s Duchenne muscular dystrophy treatment for approval.
The FDA, which does not have to follow the recommendation of this committee, has already shown caution in approving Sarepta’s eteplirsen drug. In January, Sarepta requested that the FDA review its original assessment of the drug, which found insufficient evidence of effectiveness. Last week, the FDA confirmed that decision:
“[W]e do not agree with the applicant's characterization of inaccuracies in the initial FDA briefing document... 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.”
Duchenne muscular dystrophy, which affects about one in every 3,500 to 5,000 males, is an inherited degenerative disorder with no current cure. Several patients and their families were in attendance at the committee meeting today.
Shares of SRPT have been extremely volatile as the company has battled with the FDA. After last week’s review board decision, Sarepta plunged nearly 45%. The stock recovered nearly 30% before the weekend.
Although this is the latest blow in a series of losses in the company’s fight with the FDA, there may be some hope yet. The FDA plans to hold another general review for the drug on May 26.
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