Sarepta Therapeutics, Inc. (NASDAQ:SRPT) Files An 8-K Regulation FD Disclosure
Item 7.01 Regulation FD Disclosure.
Earlier today, Sarepta Therapeutics, Inc. (the “Company”) presented 9-month functional and creatine kinase (CK) data from baseline from the 4 patients in the Phase 1 open-label study of the Company’s micro-dystrophin gene therapy candidate for Duchenne muscular dystrophy. As of the conference call this morning, Patient 3’s last CK measured 18,855 at Day 270, the last date measured. After the conference call, the Company received an update on Patient 3, whose Day 360 visit was today (March 25, 2019). Patient 3’s CK level dropped to 6,410. The Company is sharing this new information in light of the proximity of this measure to this morning’s update. The Company does not intend to provide further updates on this Phase 1 study while the confirmatory trials are ongoing.
The information in this report furnished to Item 7.01 shall not be deemed “filed” for the purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of that section. It may only be incorporated by reference in another filing under the Exchange Act or the Securities Act of 1933, as amended, if such subsequent filing specifically references the information furnished to Item 7.01 of this report.
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.