ELEVIDYS Label Changes and Pipeline Progress Could Be a Game Changer for Sarepta Therapeutics (SRPT)

• In November 2025, Sarepta Therapeutics announced progress in its Phase 1/2 clinical study of SRP-1003 for myotonic dystrophy, and provided updates to the prescribing information for ELEVIDYS, its approved gene therapy for Duchenne muscular dystrophy, including a new boxed warning for acute liver risks and label changes affecting patient eligibility.
• The updates also trigger a milestone payment of US$200 million to Arrowhead Pharmaceuticals and highlight ongoing collaboration efforts to expand Sarepta’s siRNA-based therapeutic pipeline for neuromuscular and pulmonary diseases.
• We'll consider how the ELEVIDYS label changes and ongoing clinical developments may influence Sarepta's investment outlook and risk profile.

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Sarepta Therapeutics Investment Narrative Recap

To be a Sarepta Therapeutics shareholder, you need confidence in the company’s ability to innovate and expand its rare disease portfolio despite considerable regulatory, safety, and operational hurdles. The November 2025 label update for ELEVIDYS, adding a boxed warning for acute liver injury and restricting patient eligibility, appears to materially increase near-term regulatory risk and could complicate Sarepta’s most important short-term revenue driver: broadening ELEVIDYS adoption.

These prescribing changes are significant because they could affect physician and patient confidence, impacting both ongoing uptake and future growth of ELEVIDYS. While Sarepta is advancing its siRNA pipeline, the immediate relevance of this update lies in how safety concerns might delay or reduce revenue recognition from its flagship therapy, shaping both risk and opportunity in the months ahead.

In contrast, the potential for further operational bottlenecks and clinical setbacks is something investors should be aware of...

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

Sarepta Therapeutics' outlook anticipates $1.4 billion in revenue and $171.6 million in earnings by 2028. This corresponds to a 17.0% annual decline in revenue, but a $229.6 million increase in earnings from the current level of -$58.0 million.

Uncover how Sarepta Therapeutics' forecasts yield a $21.55 fair value, a 22% upside to its current price.

Exploring Other Perspectives

Across 10 estimates, the Simply Wall St Community values Sarepta Therapeutics between US$21.55 and US$168.51 per share. With label changes for ELEVIDYS now highlighting safety risks, your own opinion on future uptake and revenue growth could make all the difference, explore several viewpoints before deciding where you stand.

Explore 10 other fair value estimates on Sarepta Therapeutics - why the stock might be worth over 9x more 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 and 1 important warning sign 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.

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