In three weeks, the US Food and Drug Administration will decide one of the most contentious issues the agency has tackled in some time — whether to approve a drug for Duchenne muscular dystrophy, a rare and fatal muscle-wasting disease that afflicts about 13,000 children, mostly boys.
And speculation is intensifying over the FDA’s decision. After Sarepta Therapeutics, which makes the drug, released earnings today but did not provide any new updates, Wall Street reacted with apprehension. Sarepta stock, which has been volatile, dropped slightly. And two analysts issued reports containing gloomy bets about whether the agency will approve the drug, called eteplirsen, on May 26.
