Last Update 03 Feb 26

Fair value Increased 14%

CAPR: Phase 3 Duchenne Cardiac Results Will Shape Bullish 2026 Approval Path

Narrative Update

The analyst price target for Capricor Therapeutics has moved from about US$44.56 to US$50.80, with analysts pointing to expectations around Phase 3 HOPE-3 data for Deramiocel in Duchenne muscular dystrophy cardiomyopathy and updated modeling assumptions as key drivers of the change.

Analyst Commentary

Recent Street research points to a change in how some analysts are framing risk and potential reward around Capricor Therapeutics, especially with Phase 3 HOPE-3 data for Deramiocel in Duchenne muscular dystrophy cardiomyopathy expected in Q4.

Bullish Takeaways

Bullish analysts have raised their valuation assumptions, reflected in a price target move to US$13 from US$12. This indicates that they now factor in a higher perceived value for Deramiocel within their models.
These analysts expect HOPE-3 to at least show evidence of cardiac improvement. They see this as a key clinical execution milestone that could support future regulatory discussions.
They view the potential for regulatory flexibility, if cardiac benefit is shown, as an important upside lever that could shorten the path to a potential approval in Duchenne muscular dystrophy cardiomyopathy.
Their models assume Deramiocel approval in this sub-disease area. This supports more optimistic views on Capricor’s longer term revenue potential and justifies the upward adjustment to the target.

Bearish Takeaways

Bearish analysts may point out that current bullish targets rely on HOPE-3 showing cardiac benefit. Any data that falls short of that expectation could challenge the assumptions behind existing valuations.
There is execution risk around using positive Phase 3 data to secure regulatory flexibility. This is not guaranteed and could extend timelines if regulators take a more conservative stance.
Because some models already build in approval in Duchenne muscular dystrophy cardiomyopathy, there is less room for upside if outcomes or regulatory feedback align only with these existing expectations rather than exceeding them.
Investors who are more cautious may see the reliance on a single late stage program and a focused sub-disease indication as a concentration risk for both growth and valuation durability.

What's in the News

Capricor plans to submit the full HOPE-3 clinical study report and supporting data for Deramiocel to the FDA in February 2026 to address a Complete Response Letter related to its Biologics License Application, with the FDA not requesting additional clinical studies or new patient data at this stage (regulatory update).
The company announced positive topline results from the pivotal Phase 3 HOPE-3 trial in boys and young men with Duchenne muscular dystrophy, reporting a favorable safety and tolerability profile for Deramiocel and planning detailed data disclosures at a future scientific meeting and in a peer-reviewed journal (product-related announcement).
Parent Project Muscular Dystrophy is hosting a community webinar to share and discuss the positive HOPE-3 topline results and outline how they inform Capricor’s ongoing regulatory discussions with the FDA, including next steps, aimed at patients and families (patient community outreach).
Capricor has an exclusive commercialization and distribution agreement for Deramiocel in DMD in the United States and Japan with Nippon Shinyaku Co. Ltd. and its U.S. subsidiary NS Pharma, Inc., subject to regulatory approval (commercial partnership).
The company completed a US$150m follow on equity offering of 6,000,000 shares of common stock at US$25 per share, reflecting access to additional capital around the late stage development of Deramiocel (financing event).

Valuation Changes

Fair Value: Updated analyst fair value moved from about US$44.56 to US$50.80, reflecting a higher modeled valuation for Capricor Therapeutics.
Discount Rate: The discount rate shifted slightly from 7.03% to about 7.04%, indicating only a very small change in the risk input used in analyst models.
Revenue Growth: Revenue growth assumptions were revised from about 156% to a very large value of around 177%, signaling a higher growth outlook being used in projections.
Net Profit Margin: Net profit margin assumptions moved from roughly 41.58% to about 33.40%, implying analysts are now using a lower profitability level in their updated models.
Future P/E: The future P/E multiple increased from about 31.53x to around 35.57x, suggesting analysts are applying a higher earnings multiple to Capricor’s projected results.

Strong pipeline in rare disease therapies and advanced platforms positions Capricor for regulatory support, market demand, and diversified future revenue streams.
Solid financial position and manufacturing readiness reduce dilution risk, enabling quicker commercialization and improved earnings stability.
Reliance on a single late-stage therapy amid regulatory setbacks, rising costs, and increasing competition heightens risks to revenue timing, earnings visibility, and long-term growth.

Catalysts

About Capricor Therapeutics

A clinical-stage biotechnology company, engages in the development of transformative cell and exosome-based therapeutics for treating duchenne muscular dystrophy (DMD) and other diseases with unmet medical needs in the United States.What are the underlying business or industry changes driving this perspective?

The continued rise in the global prevalence of rare and genetic diseases is directly fueling unmet medical needs in areas like Duchenne Muscular Dystrophy (DMD), placing Capricor's Deramiocel in a strong position for regulatory support and future market demand, which could drive substantial revenue growth upon successful approval.
With growing adoption of personalized and precision medicine, Capricor's advanced exosome platform is now in the clinic with StealthX, broadening potential future applications (beyond vaccines) and strategic partnerships, enabling pipeline diversification and supporting future earnings growth and revenue stability.
Increasing healthcare spending in developed markets and the patient-centric focus of recent FDA leadership enhance the probability of reimbursement and broad adoption for therapies like Deramiocel that target high-burden, underserved pediatric diseases, which could improve both top-line revenue and net margins post-approval.
Capricor's strong cash position ($122.8M), combined with the potential to receive a priority review voucher and an $80M milestone payment upon approval, provides a cushion to minimize dilution risk and support commercial launch, which may positively impact future earnings per share and reduce financing overhang.
Advancements in regulatory pathways for rare diseases and cell therapies, along with Capricor's demonstrated manufacturing readiness and quality approvals, set the stage for accelerated approval and commercialization, shortening the path to revenue generation and potentially expanding gross margins earlier than currently reflected in the stock.

Capricor Therapeutics Earnings and Revenue Growth

Capricor Therapeutics Future Earnings and Revenue Growth

Assumptions

How have these above catalysts been quantified?

Analysts are assuming Capricor Therapeutics's revenue will grow by 115.7% annually over the next 3 years.
Analysts assume that profit margins will increase from -522.5% today to 10.7% in 3 years time.
Analysts expect earnings to reach $14.4 million (and earnings per share of $0.29) by about September 2028, up from $-70.0 million today.
In order for the above numbers to justify the analysts price target, the company would need to trade at a PE ratio of 80.0x on those 2028 earnings, up from -4.1x today. This future PE is greater than the current PE for the US Biotechs industry at 15.5x.
Analysts expect the number of shares outstanding to grow by 0.54% per year for the next 3 years.
To value all of this in today's terms, we will use a discount rate of 6.78%, as per the Simply Wall St company report.

Capricor Therapeutics Future Earnings Per Share Growth

Risks

What could happen that would invalidate this narrative?

The late-stage pipeline remains highly concentrated around Deramiocel for DMD cardiomyopathy, and recent regulatory challenges-including a surprise FDA complete response letter (CRL) and uncertainty around acceptable efficacy endpoints-highlight the risk that any clinical or approval setbacks could result in prolonged revenue delays and reduced earnings visibility.
The company currently generates no commercial revenue and is sustaining high and rising R&D and operating costs ($36.3M R&D spend in H1 2025 versus $21.8M H1 2024, with net loss doubling year-over-year), putting pressure on cash burn and increasing the likelihood of future dilution if regulatory approval or commercial launches are delayed, negatively impacting future earnings per share.
Heightened regulatory unpredictability and shifting FDA guidelines for rare disease and cell/gene therapies-evident in the abrupt change in feedback, advisory committee cancellation, and unclear primary endpoint discussion-expose Capricor to extended approval timelines and potentially greater costs, which risks further delays in market access and revenue realization.
The long-term industry trend of accelerating competition in genetic and regenerative medicine increases the risk that, during Capricor's extended regulatory process, other entrants (especially larger or better-capitalized biopharmas) may develop superior or faster-to-market DMD or cardiomyopathic therapies, potentially eroding Capricor's future market share and revenue potential.
While the exosome platform offers long-term pipeline diversity, it is still in very early clinical stages, faces significant scientific and commercial uncertainty, and has not been a core focus for investment; thus, Capricor remains vulnerable to the risk that if its lead program stumbles, backup revenue streams will take years to materialize, hampering both long-term revenue growth and margin improvement.

Valuation

How have all the factors above been brought together to estimate a fair value?

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.
In order for you to agree with the analyst's consensus, you'd need to believe that by 2028, revenues will be $134.4 million, earnings will come to $14.4 million, and it would be trading on a PE ratio of 80.0x, assuming you use a discount rate of 6.8%.
Given the current share price of $6.28, the analyst price target of $20.6 is 69.5% higher.
We always encourage you to reach your own conclusions though. So sense check these analyst numbers against your own assumptions and expectations based on your understanding of the business and what you believe is probable.

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Disclaimer

AnalystConsensusTarget is a tool utilizing a Large Language Model (LLM) that ingests data on consensus price targets, forecasted revenue and earnings figures, as well as the transcripts of earnings calls to produce qualitative analysis. The narratives produced by AnalystConsensusTarget are general in nature and are based solely on analyst data and publicly-available material published by the respective companies. These scenarios are not indicative of the company's future performance and are exploratory in nature. Simply Wall St has no position in the company(s) mentioned. Simply Wall St may provide the securities issuer or related entities with website advertising services for a fee, on an arm's length basis. These relationships have no impact on the way we conduct our business, the content we host, or how our content is served to users. The price targets and estimates used are consensus data, and do not constitute a recommendation to buy or sell any stock, and they do not take account of your objectives, or your financial situation. Note that AnalystConsensusTarget's analysis may not factor in the latest price-sensitive company announcements or qualitative material.

Future FDA Approvals Will Expand Rare Disease Treatments