$SRPT Sarepta Therapeutics Halted Afterhours.
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.
Source seeking alpha
Sarepta Therapeutics, Inc. is a commercial-stage biopharmaceutical company, which is engaged in the discovery and development of therapeutics for the treatment of rare diseases. The company was founded on July 22, 1980 and is headquartered in Cambridge, MA.
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.
Source seeking alpha
Sarepta Therapeutics, Inc. is a commercial-stage biopharmaceutical company, which is engaged in the discovery and development of therapeutics for the treatment of rare diseases. The company was founded on July 22, 1980 and is headquartered in Cambridge, MA.