Press release
Sarepta Therapeutics Announces Initiation of EMBARK, a Global Pivotal Study of SRP-9001, a Gene Therapy for the Treatment of Duchenne Muscular Dystrophy
- Sarepta to host “SRP-9001 Micro-dystrophin R&D Day” at 8:30 a.m. Eastern Time on Monday, Oct. 11, 2021 CAMBRIDGE, Mass., Oct. 04, 2021 (GLOBE NEWSWIRE) --
About this update from Sarepta Therapeutics, Inc.
[{"type":"text","content":"- Sarepta to host “SRP-9001 Micro-dystrophin R&D Day” at 8:30 a.m. Eastern Time on Monday, Oct. 11, 2021 CAMBRIDGE, Mass., Oct. 04, 2021 (GLOBE NEWSWIRE) -- Sarepta Therapeutics, Inc. (NASDAQ:SRPT), the leader in precision genetic medicine for rare diseases, today announced the initiation, in partnership with Roche, in the U.S. and countries around the world, of study SRP-9001-301, also known as EMBARK, a pivotal study of SRP-9001 (rAAVrh74.MHCK7.micro-dystrophin) for the treatment of Duchenne muscular dystrophy. SRP-9001 is an investigational gene transfer therapy intended to deliver its micro-dystrophin-encoding gene to muscle tissue for the targeted production of the micro-dystrophin protein. “We are delighted to announce the initiation of EMBARK, representing the first pivotal double-blind gene therapy trial in Duchenne which will be initiated in US, Europe and Asia,” said Doug Ingram, president and chief executive officer, Sarepta. “The initiation of EMBARK represents the culmination of enormous effort and success from a research, development and manufacturing perspective and is an extraordinarily important moment for the patient community and a leap forward in our effort to change the course of Duchenne. In addition to our team, our investigators and the families who have participated in our trials, I want to thank the professionals within FDA’s Office of Tissues and Advanced Therapies for their collaborative guidance and insight as we finalized our EMBARK study and advance the SRP-9001 program. We look forward to sharing the particulars of EMBARK and additional functional data from our prior studies in our upcoming ‘Micro-dystrophin Day’.” The Company will host an SRP-9001 Micro-dystrophin R&D Day on Monday, Oct. 11, 2021, at 8:30 am Eastern Time. The presentation will be webcast live under the investor relations section of Sarepta's website at https://investorrelations.sarepta.com/events-presentations and slides will be archived there following the call for one year. Please connect to Sarepta's website several minutes prior to the start of the broadcast to ensure adequate time for any software download that may be necessary. The conference call may be accessed by dialing (844) 534-7313 for domestic callers and (574) 990-1451 for international callers. The passcode for the call is 3878397. Please specify to the operator t...