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    Sarepta Therapeutics (SRPT) Is Up 6.8% After FDA Clears Cohort 8 Dosing in ENDEAVOR Trial

    Simply Wall St·12/09/2025 10:12:02
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    • In November 2025, Sarepta Therapeutics announced that the FDA had approved dosing in Cohort 8 of its ENDEAVOR trial, allowing evaluation of an enhanced immunosuppression regimen for ELEVIDYS in non-ambulant Duchenne muscular dystrophy patients, after the therapy had already been used in over 1,100 individuals worldwide.
    • This regulatory step could be important for understanding how to extend ELEVIDYS beyond ambulant patients while managing safety issues such as liver injury, thrombocytopenia, and elevated troponin.
    • Next, we’ll examine how FDA approval to start Cohort 8 dosing for non-ambulant patients may influence Sarepta’s existing investment narrative.

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    Sarepta Therapeutics Investment Narrative Recap

    To be a Sarepta shareholder today, you need to believe ELEVIDYS can remain a meaningful Duchenne franchise while the company manages serious safety concerns and complex gene therapy logistics. FDA approval to start dosing Cohort 8 in non ambulant patients looks directionally positive for Sarepta’s near term label expansion efforts, but it does not remove the central risk around acute liver injury and the impact that safety scrutiny can have on uptake and revenue timing.

    The recent ELEVIDYS label update on November 14, 2025, which added a boxed warning for acute liver injury and acute liver failure and removed the non ambulatory indication, sits directly behind this new Cohort 8 decision. Together, these steps frame the key catalyst around restoring access for non ambulant patients while operating under tighter monitoring, and they highlight how closely future growth prospects are tied to ongoing safety data and FDA interactions.

    Yet investors should be aware that the same safety issues now being managed in Cohort 8 also raise questions about...

    Read the full narrative on Sarepta Therapeutics (it's free!)

    Sarepta Therapeutics' narrative projects $1.4 billion revenue and $171.6 million earnings by 2028. This assumes revenues will decline by 17.0% per year and requires a $229.6 million earnings increase from -$58.0 million today.

    Uncover how Sarepta Therapeutics' forecasts yield a $19.91 fair value, a 9% downside to its current price.

    Exploring Other Perspectives

    SRPT 1-Year Stock Price Chart
    SRPT 1-Year Stock Price Chart

    Ten fair value estimates from the Simply Wall St Community range from US$19.91 to US$168.51, showing how far apart individual views on Sarepta really are. You can weigh those opinions against the central catalyst of ELEVIDYS label evolution, where broadened access and tighter safety oversight could both shape how the business performs over time.

    Explore 10 other fair value estimates on Sarepta Therapeutics - why the stock might be worth 9% less than the current price!

    Build Your Own Sarepta Therapeutics Narrative

    Disagree with existing narratives? Create your own in under 3 minutes - extraordinary investment returns rarely come from following the herd.

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    This article by Simply Wall St is general in nature. We provide commentary based on historical data and analyst forecasts only using an unbiased methodology and our articles are not intended to be financial advice. It does not constitute a recommendation to buy or sell any stock, and does not take account of your objectives, or your financial situation. We aim to bring you long-term focused analysis driven by fundamental data. Note that our analysis may not factor in the latest price-sensitive company announcements or qualitative material. Simply Wall St has no position in any stocks mentioned.