Sarepta Therapeutics, Inc. (NASDAQ:SRPT) Files An 8-K Financial Statements and ExhibitsItem 9.01
|99.1||Press release dated March12, 2018.|
Sarepta Therapeutics, Inc. ExhibitEX-99.1 2 d549342dex991.htm EX-99.1 EX-99.1 Exhibit 99.1 Sarepta Therapeutics Announces Plan to Submit a New Drug Application (NDA) for Accelerated Approval of Golodirsen (SRP-4053) in Patients with Duchenne Muscular Dystrophy (DMD) Amenable to Skipping Exon 53 The Company met with the FDA Division of Neurology Products in February to obtain guidance on the regulatory pathway for golodirsen The Company intends to complete a rolling NDA submission for golodirsen by year-end 2018 CAMBRIDGE,…To view the full exhibit click
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.