Regulatory update and why it matters for Capricor investors

Capricor Therapeutics (CAPR) shares are in focus after the company reported a new step in the U.S. regulatory process for Deramiocel, its investigational cell therapy for Duchenne muscular dystrophy.

The FDA has requested the full Phase 3 HOPE-3 clinical study report and supporting data to address a prior Complete Response Letter, without asking for new clinical trials or additional patient data.

Capricor’s latest FDA update arrives after a sharp 90-day share price return of 282.20% from a recent pullback. Its 1-year total shareholder return of 65.52% and very large 3-year total shareholder return suggest earlier investors have already seen substantial swings in sentiment.

If this kind of regulatory milestone has your attention, it could be a good moment to scan other healthcare stocks that might be reshaping expectations in the sector.

With Capricor trading at US$23.62 against an analyst price target of US$50.80 and flagged as having an intrinsic discount of about 91%, you have to ask: is this still mispriced, or is the market already baking in future growth?

Most Popular Narrative: 47% Undervalued

Capricor’s most followed narrative pegs fair value around $44.56 per share versus the last close at $23.62, setting up a wide valuation gap that hinges on how Deramiocel and the wider pipeline play out.

The analysts have a consensus price target of $20.6 for Capricor Therapeutics based on their expectations of its future earnings growth, profit margins and other risk factors. However, there is a degree of disagreement amongst analysts, with the most bullish reporting a price target of $29.0, and the most bearish reporting a price target of just $12.0.

Curious what justifies a fair value that runs well ahead of current trading levels and past price targets? The narrative focuses on scenarios involving rapid revenue expansion, a sharp swing into profitability, and a future earnings multiple more often associated with higher growth sectors. Want to see exactly how those assumptions are combined and the time frame over which that growth is modeled? Read the full story behind the numbers.

Result: Fair Value of $44.56 (UNDERVALUED)

However, that story can unravel quickly if Deramiocel faces additional regulatory setbacks or if prolonged losses and cash burn force heavier dilution than analysts currently model.

Build Your Own Capricor Therapeutics Narrative

If you see the numbers differently or prefer to weigh the data on your own terms, you can build a personalized thesis for Capricor in minutes: Do it your way.

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.

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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.