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Max Nisen

We May Soon Learn Just How Flexible Scott Gottlieb's FDA Is

Another new DMD drug could spark another approval controversy.
Photographer: Zach Gibson

One the FDA's biggest controversies is coming back to test its new leadership. 

Sarepta Therapeutics Inc. on Wednesday released promising early data from a study of a new drug to treat some patients with the rare muscle-wasting disease Duchenne Muscular Dystrophy (DMD). The drug is a follow-up to Exondys 51, another DMD treatment the FDA approved last year -- over the objection of some of its own scientists -- to treat a different subset of patients. The company plans to ask the FDA if it can seek accelerated approval of the medicine, according to Leerink analyst Joseph Schwartz. Its shares rose 11 percent on Wednesday.