Sarepta Therapeutics Inc ELEVIDYS FDA Accelerated Approval Call Transcript

Jun 22, 2023 / 08:30PM GMT
Operator

Good afternoon, and welcome to the Sarepta Therapeutics ELEVIDYS FDA accelerated approval call. (Operator Instructions) As a reminder, today's program is being recorded. At this time, I'll turn the call over to Doug Ingram, President and CEO of Sarepta Therapeutics. Please go ahead.

Douglas S. Ingram - Sarepta Therapeutics, Inc. - President, CEO & Director

Thank you, Victor. And thank you all for joining us for this call to discuss the approval and launch of the first and only approved gene therapy for Duchenne muscular dystrophy. Mary, next slide. I will be making some forward-looking statements. Please refer to our public filings for the various risks and uncertainties that exist with statements and predictions about the future. Next slide. As you know, earlier today, the FDA approved RP SRP-9001, delandistrogene moxeparvovec-rokl for the treatment of Duchenne patients. The division has initially approved the therapy for Duchenne patients aged 4 through 5 years with our ongoing Phase III trial EMBARK, acting as the confirmatory study for the approval. And

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