Sarepta Therapeutics Inc Q2 2023 Earnings Call Summary - Thomson StreetEvents

Sarepta Therapeutics Inc Q2 2023 Earnings Call Summary

Sarepta Therapeutics Inc Q2 2023 Earnings Call Summary - Thomson StreetEvents
Sarepta Therapeutics Inc Q2 2023 Earnings Call Summary
Published Aug 02, 2023
15 pages (8595 words) — Published Aug 02, 2023
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Abstract:

Edited Brief of SRPT.OQ earnings conference call or presentation 2-Aug-23 8:30pm GMT

  
Brief Excerpt:

...A. With a majority vote, the advisory committee recommended the approval of ELEVIDYS for the treatment of ambulatory patients with Duchenne muscular dystrophy. B. On June 22, the FDA granted an accelerated approval for ELEVIDYS to treat Duchenne muscular dystrophy, currently labeled for 4- and 5-year-old patients. C. We will have the top line for EMBARK in the fourth quarter of this year. D. If successful, we should be able to expand our label in the first half of 2024 to include the majority of Duchenne patients. E. Our goal is to expand our label for ELEVIDYS to cover as much as 95% of the Duchenne patients. F. ELEVIDYS is our fourth approved Duchenne therapy, and we have been very successful with all of our prior launches. G. In fact, I am pleased to announce that the first reimbursed ELEVIDYS infusion occurred earlier today. H. In fact, we have 24 ongoing human clinical trials by the end of this year. I. And we continue to advance our next-generation viral capsid, Myo AAV, which in...

  
Report Type:

Brief

Source:
Company:
Sarepta Therapeutics Inc
Ticker
SRPT.OQ
Time
8:30pm GMT
Format:
PDF Adobe Acrobat
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The following is excerpted from the question-and-answer section of the transcript.

(Questions from industry analysts are provided in full, but answers are omitted - download the transcript to see the full question-and-answer session)

Question: Colin Nigel Bristow - UBS Investment Bank, Research Division - Analyst : Congrats on another mark then with the first patient dosed. I guess a sort of 2-part question around the comments you made around EMBARK. Hitting with as low as a 1.3 point delta. I'm curious, what is the powering the 1.3 delta is at? And has there been any discussion with FDA whether this would be considered clinically meaningful? And then just as a sort of follow-up on that, I think the most common question we're getting is that if EMBARK misses the primary and the overall population that shows a directional benefit in 4- to 5-year-olds, given there's no multiplicity strategy, has the FDA given any indication on whether this would be sufficient to maintain the approval status? REFINITIV STREETEVENTS | www.refinitiv.com | Contact Us consent of Refinitiv. 'Refinitiv' and the Refinitiv logo are registered trademarks of Refinitiv and its affiliated companies. AUGUST 02, 2023 / 8:30PM, SRPT.OQ - Q2 2023 Sarepta Therapeutics Inc Earnings Call


Question: Kristen Brianne Kluska - Cantor Fitzgerald & Co., Research Division - Analyst : Congrats on today's milestone. Given that you're taking all these steps now across sites, payers and antibody testing, is it your expectation that if you end up getting a broader label in the first half of next year, that the 3- to 4-month timeline you've commuted -- you've communicated to us in terms of patients getting on therapy could be shortened?

Table Of Contents

Sarepta Therapeutics Inc Update Call Summary – 2023-10-30 – US$ 54.00 – Edited Brief of SRPT.OQ conference call or presentation 30-Oct-23 8:30pm GMT

Sarepta Therapeutics Inc Update Call Transcript – 2023-10-30 – US$ 54.00 – Edited Transcript of SRPT.OQ conference call or presentation 30-Oct-23 8:30pm GMT

Sarepta Therapeutics Inc at Morgan Stanley Global Healthcare Conference Summary – 2023-09-11 – US$ 54.00 – Edited Brief of SRPT.OQ presentation 11-Sep-23 12:40pm GMT

Sarepta Therapeutics Inc at Morgan Stanley Global Healthcare Conference Transcript – 2023-09-11 – US$ 54.00 – Edited Transcript of SRPT.OQ presentation 11-Sep-23 12:40pm GMT

Sarepta Therapeutics Inc Q2 2023 Earnings Call Transcript – 2023-08-02 – US$ 54.00 – Edited Transcript of SRPT.OQ earnings conference call or presentation 2-Aug-23 8:30pm GMT

Sarepta Therapeutics Inc at TD Cowen RNA Therapeutics Summit (Virtual) Summary – 2023-07-10 – US$ 54.00 – Edited Brief of SRPT.OQ presentation 10-Jul-23 3:00pm GMT

Sarepta Therapeutics Inc at TD Cowen RNA Therapeutics Summit (Virtual) Transcript – 2023-07-10 – US$ 54.00 – Edited Transcript of SRPT.OQ presentation 10-Jul-23 3:00pm GMT

Sarepta Therapeutics Inc ELEVIDYS FDA Accelerated Approval Call Summary – 2023-06-22 – US$ 54.00 – Edited Brief of SRPT.OQ conference call or presentation 22-Jun-23 8:30pm GMT

Sarepta Therapeutics Inc ELEVIDYS FDA Accelerated Approval Call Transcript – 2023-06-22 – US$ 54.00 – Edited Transcript of SRPT.OQ conference call or presentation 22-Jun-23 8:30pm GMT

Sarepta Therapeutics Inc Q1 2023 Earnings Call Summary – 2023-05-02 – US$ 54.00 – Edited Brief of SRPT.OQ earnings conference call or presentation 2-May-23 8:30pm GMT

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Cite this Report

  
MLA:
Thomson StreetEvents. "Sarepta Therapeutics Inc Q2 2023 Earnings Call Summary" Aug 02, 2023. Alacra Store. May 17, 2025. <http://www.alacrastore.com/thomson-streetevents-transcripts/Q2-2023-Sarepta-Therapeutics-Inc-Earnings-Call-B15670921>
  
APA:
Thomson StreetEvents. (2023). Sarepta Therapeutics Inc Q2 2023 Earnings Call Summary Aug 02, 2023. New York, NY: Alacra Store. Retrieved May 17, 2025 from <http://www.alacrastore.com/thomson-streetevents-transcripts/Q2-2023-Sarepta-Therapeutics-Inc-Earnings-Call-B15670921>
  
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