[Updated 7:25 p.m. See below.] Safety concerns stymied Sarepta Therapeutics’ attempt to win FDA approval last August for golodirsen (Vyondys 53), its second Duchenne muscular dystrophy drug. But an appeal of the decision led to a surprise reversal by the regulator last month, with little explanation why.
Details are now surfacing about the safety risks that led the FDA to initially reject the therapy. And the regulator contends that much more would be known about the extent of those risks if Sarepta (NASDAQ: SRPT) had conducted a study it was ordered to start in 2016 as a… Read more »
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