• Capricor Therapeutics recently reported that the FDA, after reviewing topline Phase 3 HOPE-3 data for Deramiocel in Duchenne muscular dystrophy, has issued a request for the full clinical study report and supporting data to address a prior Complete Response Letter, without asking for new clinical trials or patient data.
• The company aims to submit the HOPE-3 report in February 2026, a step that could clarify the regulatory path for this first-in-class cell therapy candidate with multiple expedited designations.
• We’ll now examine how the FDA’s request for the full HOPE-3 study report shapes Capricor’s investment narrative around Deramiocel’s regulatory prospects.

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What Is Capricor Therapeutics' Investment Narrative?

For anyone considering Capricor today, the big picture really comes down to conviction in Deramiocel as a potential first commercial product and the company’s ability to manage through a binary FDA process while burning cash. The latest FDA update, asking for the full HOPE-3 study report but not new trials, keeps the core near term catalyst squarely on the regulatory side rather than shifting it back to the clinic. That matters because the stock has already re-rated hard on HOPE-3 topline data, yet the business remains loss-making and heavily dependent on a single asset. In the short run, investors are watching for the February 2026 submission and the potential for a new PDUFA date, while the key risks remain regulatory pushback, time to any potential approval and ongoing dilution to fund operations.

However, one risk in particular could catch new shareholders off guard if they are not watching closely. Despite retreating, Capricor Therapeutics' shares might still be trading above their fair value and there could be some more downside. Discover how much.

Exploring Other Perspectives

Seven Simply Wall St Community fair value views span roughly US$16 to over US$250 per share, underscoring how far opinions diverge on Capricor’s upside. Set against that spread, the current focus on Deramiocel’s FDA review and funding needs means your own view on regulatory risk and future capital raises will heavily influence how you interpret those community numbers.

Explore 7 other fair value estimates on Capricor Therapeutics - why the stock might be worth over 10x more than the current price!

Build Your Own Capricor Therapeutics Narrative

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

• A great starting point for your Capricor Therapeutics research is our analysis highlighting 3 key rewards and 1 important warning sign that could impact your investment decision.
• Our free Capricor Therapeutics research report provides a comprehensive fundamental analysis summarized in a single visual - the Snowflake - making it easy to evaluate Capricor 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.