Sarepta spikes after accelerated FDA approval of Duchenne treatment

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.

https://seekingalpha.com/news/3526041-sarepta-therapeutics-spikes-after-accelerated-fda-approval-of-dmd-treatment