The Bull Case For Sarepta Therapeutics (SRPT) Could Change Following ESSENCE Trial Miss and FDA Discussions

On November 3, 2025, Sarepta Therapeutics reported that its Phase 3 ESSENCE trial for Duchenne muscular dystrophy therapies AMONDYS 45 and VYONDYS 53 did not meet the primary endpoint, though numerical trends favored the treatments and safety was comparable to placebo. Despite missing statistical significance in the primary outcome, Sarepta highlighted encouraging results in non-COVID impacted participants and intends to discuss potential conversion to traditional approval with the FDA, supported by substantial real-world evidence and a stable safety profile. We'll consider how Sarepta's ESSENCE trial outcome and upcoming FDA discussions might reshape the company's investment outlook and risk profile.

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Sarepta Therapeutics Investment Narrative Recap

The investment thesis for Sarepta Therapeutics centers on the company’s ability to bring innovative therapies for neuromuscular diseases to market, with regulatory milestones and safety updates as major drivers. The recent Phase 3 ESSENCE trial’s failure to achieve statistical significance could have a near-term impact on confidence around regulatory approvals and heightens focus on Sarepta’s FDA discussions, while operational and safety risks around key gene therapy programs remain core concerns for shareholders.

Among recent announcements, Sarepta’s lowered 2025 revenue guidance, from a previous range of US$2,900 million to US$3,100 million down to US$2,300 million to US$2,600 million, stands out as particularly relevant. This revision reflects the company’s response to slower-than-expected uptake and highlights how closely near-term growth depends on regulatory outcomes for its core therapies.

But investors should also be aware of emerging risks tied to patient safety and regulatory scrutiny, particularly as...

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

Sarepta Therapeutics is forecast to reach $1.4 billion in revenue and $171.6 million in earnings by 2028. This outlook is based on a 17.0% annual decline in revenue and a $229.6 million increase in earnings from the current level of -$58.0 million.

Uncover how Sarepta Therapeutics' forecasts yield a $22.88 fair value, a 6% downside to its current price.

Exploring Other PerspectivesSRPT Community Fair Values as at Nov 2025

Ten fair value estimates from the Simply Wall St Community span US$22.88 to US$168.51 per share, underscoring highly varied market opinions. With recent trial uncertainty increasing regulatory risk, it is worth examining these contrasting viewpoints on Sarepta's future closely.

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Explore 10 other fair value estimates on Sarepta Therapeutics - why the stock might be worth 6% 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.

A great starting point for your Sarepta Therapeutics research is our analysis highlighting 3 key rewards that could impact your investment decision. Our free Sarepta Therapeutics research report provides a comprehensive fundamental analysis summarized in a single visual - the Snowflake - making it easy to evaluate Sarepta Therapeutics' overall financial health at a glance.

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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.

Companies discussed in this article include SRPT.

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