Sarepta Therapeutics (SRPT) Is Up 14.6% After FDA Clears ELEVIDYS Shipments Amid Legal Scrutiny

• In recent days, Sarepta Therapeutics announced the resumption of ELEVIDYS gene therapy shipments for ambulatory Duchenne patients following FDA clearance, after previous market pauses due to safety concerns and reports of patient deaths.
• While the company reported strong second-quarter results and resumed deliveries, it continues to face ongoing regulatory scrutiny and multiple class action lawsuits tied to ELEVIDYS safety disclosures.
• We'll examine how FDA approval to restart ELEVIDYS shipments impacts Sarepta's investment outlook amid ongoing legal and regulatory headwinds.

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Sarepta Therapeutics Investment Narrative Recap

To be a Sarepta Therapeutics shareholder, you have to believe in the long-term promise of gene therapy for Duchenne muscular dystrophy and in the company’s ability to address evolving regulatory and safety scrutiny. The recent FDA clearance for resuming ELEVIDYS shipments to ambulatory patients removes a key near-term overhang, but continued monitoring of safety and class action litigation remains the biggest business risk. For now, the FDA’s decision appears material to short-term momentum while not eliminating ongoing legal uncertainties.

Among the recent updates, the second-quarter earnings report is especially relevant: Sarepta delivered US$611.09 million in quarterly revenue, a sharp increase over the prior year, supported by resuming ELEVIDYS sales. However, this operational and financial rebound remains closely tied to future regulatory decisions and product acceptance, both of which are shaped by evolving safety data and ongoing legal issues.

However, investors should be aware that several class action lawsuits alleging misleading safety communications are still unresolved and...

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

Sarepta Therapeutics' outlook anticipates $1.3 billion in revenue and $82.3 million in earnings by 2028. This scenario is based on an annual revenue decline of 16.1% and an earnings increase of $330.7 million from the current -$248.4 million.

Uncover how Sarepta Therapeutics' forecasts yield a $22.16 fair value, a 22% upside to its current price.

Exploring Other Perspectives

Ten fair value estimates from the Simply Wall St Community span a broad range from US$22.16 to US$182.67 per share. Given this diversity of opinion, especially as regulatory risks and safety concerns remain in focus, it is clear that future outcomes could vary widely depending on the risks that play out.

Explore 10 other fair value estimates on Sarepta Therapeutics - why the stock might be worth just $22.16!

Build Your Own Sarepta Therapeutics Narrative

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• 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.
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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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