Sarepta Therapeutics, Inc. (NASDAQ:SRPT) Files An 8-K Other Events
Item 8.01. Other Events.
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.
This Current Report on Form 8-K contains certain forward-looking statements. All statements other than historical or current facts are forward-looking statements, including, without limitation, the statement regarding the expected regulatory action date of August 19, 2019. These forward-looking statements involve risks and uncertainties, many of which are beyond the Company’s control. Known risk factors include, among others: the Company may not be able to complete clinical trials required by the FDA for approval of golodirsen; priority review status for golodirsen may not lead to faster development or regulatory review or approval process, and it does not increase the likelihood that golodirsen will receive marketing approval; golodirsen may not result in a viable treatment suitable for commercialization due to a variety of reasons including the results of future research may not be consistent with past positive results or may fail to meet regulatory approval requirements for the safety and efficacy of product candidates; and even if golodirsen results in a commercialized product, the Company may not achieve any significant revenues from the sale of such product; and the Company may not be able to execute on its business plans, including meeting its expected or planned regulatory milestones and timelines, clinical development plans, and bringing its products to U.S. and ex-U.S. markets for various reasons including possible limitations of company financial and other resources, manufacturing limitations that may not be anticipated or resolved for in a timely manner, and regulatory, court or agency decisions, such as decisions by the United States Patent and Trademark Office with respect to patents that cover the Company’s product candidates. The Company does not undertake any obligation to publicly update its forward-looking statements based on events or circumstances after the date hereof.
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.