Sarepta Therapeutics (NASDAQ:SRPT) +23.4% after-hours on news the Food and Drug Administration granted accelerated approval to the company's Vyondys 53 (golodirsen) injection to treat a rare Duchenne muscular dystrophy mutation.
In making its decision, the FDA says it considered the potential risks associated with the drug, the life-threatening and debilitating nature of the disease and the lack of available therapy.
As part of the accelerated approval process, the FDA requires SRPT to conduct a clinical trial to confirm the drug's clinical benefit.
Now read: Novavax: Be Careful With This One »
Try Seeking Alpha PREMIUM for unlimited analysis on SRPT