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Sarepta Announces FDA Acceptance of Golodirsen (SRP-4053) New Drug Application


On February 14, 2019, Sarepta Therapeutics, Inc. (the “Company”) announced that the United States Food and Drug Administration (“FDA”), Division of Neurology, has accepted the Company’s New Drug Application seeking accelerated approval for golodirsen (SRP-4053) and provided a regulatory action date of August 19, 2019. The FDA has also granted Priority Review Status for golodirsen.

Sarepta Announces FDA Acceptance Of Golodirsen (SRP-4053) New Drug Application