Sarepta Therapeutics, Inc. (NASDAQ:SRPT) Files An 8-K Other Events
Item 8.01 Other Events.
On December 20, 2018, Sarepta Therapeutics, Inc. announced that it has completed the submission of its New Drug Application (NDA) to the United States Food and Drug Administration (FDA) seeking approval of golodirsen (SRP-4053) in patients with Duchenne muscular dystrophy amenable to skipping exon 53.
About Sarepta Therapeutics, Inc. (NASDAQ:SRPT)
Sarepta Therapeutics, Inc. is a biopharmaceutical company. The Company is focused on the discovery and development of ribonucleic acid (RNA)-targeted therapeutics for the treatment of rare, infectious and other diseases. The Company operates in one segment: the development of pharmaceutical products on its own behalf or in collaboration with others. The Company, through its platform technologies, targets a range of diseases and disorders through RNA-targeted mechanisms of action. The Company is also developing therapeutics using its technology for the treatment of drug-resistant bacteria and infectious, rare and other human diseases. The Company’s lead Duchenne Muscular Dystrophy (DMD) product candidate, Eteplirsen, is an antisense phosphorodiamidate morpholino oligomer (PMO) therapeutic in Phase III clinical development for the treatment of individuals with DMD having an error in the gene coding for dystrophin that is amenable to skipping exon 51.