Sarepta Therapeutics Inc Update Call Summary - Thomson StreetEvents

Sarepta Therapeutics Inc Update Call Summary

Sarepta Therapeutics Inc Update Call Summary - Thomson StreetEvents
Sarepta Therapeutics Inc Update Call Summary
Published Oct 30, 2023
15 pages (8381 words) — Published Oct 30, 2023
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Abstract:

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

  
Brief Excerpt:

...A. EMBARK is a Phase III double-blind randomized controlled trial with 1:1 randomization with 125 patients enrolled. B. Biopsies are at 12 weeks at a subset of patients for an end of 31 of the 125 enrolled. C. The primary endpoint is change in NSAA from baseline to week 52. D. Key secondary endpoints are SRP-9001 dystrophin protein expression, time to rise and 10-meter walk run. E. While it's not on the slide, I'd like to note that as expected, ELEVIDYS protein expression was highly significant [a key] is less than 0.0001, as the first key secondary endpoint. F. We acknowledge that the primary endpoint of NSAA at 52 weeks did not reach statistical significance, although it favored ELEVIDYS, and I'll discuss this in more detail. G. We see significance in not only the overall population with P to 0.0025 but also in each of the age subgroups. H. As you can see from this table, treatment with ELEVIDYS reduced the odds of progressing to a rise time of greater than 5 seconds by 91%, a hugely...

  
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: Kristen Brianne Kluska - Cantor Fitzgerald & Co., Research Division - Analyst : Heading into the study, you had guided potentially to see a 1.3 point difference based off a lot of the powering assumptions, what you would need to hit for static. So given that there were a number of trial updates and other factors that you made, can you talk about how each arm essentially performed relative to what your expectations were with these powering assumptions?


Question: Colin Nigel Bristow - UBS Investment Bank, Research Division - Analyst : So first on time to horizon 10-minute walk, they seem to be trending better in the 6- to 7-year olds, which I think is contrary to what we've seen previously and what would be expected. Any comments on this? And then from a regulatory standpoint, I know this has been asked in the coming ways, but I just want to question this. Like what is your base case expectation? It sounds like it's full approval in 4 to 5, but I just wanted to confirm this. And then from a manufacturing perspective, what will you prepare for in terms of a market


Question: Gavin Clark-Gartner - Evercore ISI Institutional Equities, Research Division - Analyst : So on your FDA discussions to date, were there any different conversations on expanding the label to all ages versus expanding into all ambulation statuses? I'm just trying to get a sense if the FDA used both of these label expansion aspects together or if they may be separate considerations?

Table Of Contents

Sarepta Therapeutics To Discuss ELEVIDYS Label Update Call Summary – 2024-06-21 – US$ 54.00 – Edited Brief of SRPT.OQ conference call or presentation 21-Jun-24 12:30pm GMT

Sarepta Therapeutics Inc at UBS BioPharma Conference Transcript – 2023-11-09 – US$ 54.00 – Edited Transcript of SRPT.OQ presentation 9-Nov-23 2:00pm GMT

Sarepta Therapeutics Inc Q3 2023 Earnings Call Summary – 2023-11-01 – US$ 54.00 – Edited Brief of SRPT.OQ earnings conference call or presentation 1-Nov-23 8:30pm GMT

Sarepta Therapeutics Inc Q3 2023 Earnings Call Transcript – 2023-11-01 – US$ 54.00 – Edited Transcript of SRPT.OQ earnings conference call or presentation 1-Nov-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 Summary – 2023-08-02 – US$ 54.00 – Edited Brief of SRPT.OQ earnings conference call or presentation 2-Aug-23 8:30pm 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

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Cite this Report

  
MLA:
Thomson StreetEvents. "Sarepta Therapeutics Inc Update Call Summary" Oct 30, 2023. Alacra Store. May 17, 2025. <http://www.alacrastore.com/thomson-streetevents-transcripts/Sarepta-Therapeutics-Inc-Update-Call-B15788793>
  
APA:
Thomson StreetEvents. (2023). Sarepta Therapeutics Inc Update Call Summary Oct 30, 2023. New York, NY: Alacra Store. Retrieved May 17, 2025 from <http://www.alacrastore.com/thomson-streetevents-transcripts/Sarepta-Therapeutics-Inc-Update-Call-B15788793>
  
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