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Capricor Therapeutics (4LN2) AI Stock Analysis

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DE:4LN2

Capricor Therapeutics

(XETRA:4LN2)

Rating:―N/A
Action:N/A
Date:―

No summary available

Positive Factors
Clinical efficacyThe pivotal HOPE-3 trial produced a statistically significant efficacy result, supporting deramiocel’s potential differentiation in Duchenne muscular dystrophy. A durable treatment effect in upper-limb function could address an important unmet need and provide a credible foundation for regulatory approval and eventual commercial adoption.
Negative Factors
No commercial revenueThe absence of recognized revenue confirms that Capricor remains dependent on regulatory success before establishing a recurring product-sales base. Until deramiocel is approved and launched, the company lacks commercial operating scale, making future progress highly dependent on development execution and external funding.

Capricor Therapeutics (4LN2) vs. iShares MSCI Germany ETF (EWG)

-100%0%100%200%300%400%500%600%DE:4LN2+90.34%EWG+6.38%Dec '25Jan '26Feb '26Mar '26Apr '26May '26Jun '26Jul '26Aug '26Sep '26Oct '26Nov '26
Market Cap
EUR 649.77M
Dividend Yield
―
Average Volume (3M)
2,963
Price to Earnings (P/E)
-4.3
Beta (1Y)
1.19
Revenue Growth
-100.00%
EPS Growth
-40.84%
Country
Germany
Employees
231
Sector
Healthcare
Sector Strength
51
Industry
Biotechnology

Capricor Therapeutics Business Overview & Revenue Model

Company Description

Capricor Therapeutics, Inc. is a clinical-stage biotechnology company, which focuses on the development of transformative cell and exosome-based therapeutics for treating Duchenne muscular dystrophy (“DMD”), a rare form of muscular dystrophy which re...

Capricor Therapeutics Earnings Call Summary

Earnings Call Date:Nov 10, 2026(Q3-2026)|% Change Since:9.58%|Next Earnings Date:Mar 11, 2027
Earnings Call SentimentPositive

The call was predominantly positive, supported by a statistically significant HOPE-3 primary endpoint, favorable two-year extension and integrated-trial data, positive safety experience, cardiac-data recognition, FDA review progress, launch preparation, manufacturing readiness, and a cash runway of at least 12 months. Key negatives were the still-pending FDA decision, the ongoing NS Pharma dispute, no recognized revenue, higher operating expenses, larger net losses, a nonsignificant overall ejection-fraction result, and a 10% workforce reduction. The highlights significantly outweighed the lowlights.

Positive Updates

BLA Advances Through Final FDA Review
FDA agreed to review additional data and a major amendment to the BLA, extending the PDUFA target action date to November 22, 2026. The August amendment included approximately 30,000 pages of documents, reports, tables, listings, files, and data sets, including 24-month HOPE-3 open-label extension data, sensitivity and robustness analyses, and an integrated summary of efficacy from HOPE-2 and HOPE-3. All requested information has been submitted and the review remains ongoing.

Negative Updates

Overall Ejection Fraction Result Did Not Reach Statistical Significance
Across all patients in HOPE-3, the difference in ejection fraction compared with placebo did not reach statistical significance. Management stated that the statistically significant benefit was observed in the subgroup of patients with existing cardiomyopathy.

Company Guidance

Management said the FDA review remains ongoing with the PDUFA target action date extended to November 22, 2026, after submission of an amendment containing approximately 30,000 pages, and the proposed refined indication is for patients with age greater than 9 years old; commercial readiness is underway across distribution, patient support, market access, medical affairs, and physician education, while the San Diego GMP facility is ready for an initial launch, with the first-floor clean room able to meet the needs of 250 patients per year or around 1000 doses per year and the second floor expected to support 2,000 to 2500 patients or up to 10,000 doses per year operating at full capacity, with validation targeted for the first half of 2020; the company estimates approximately 15,000 people in The US are living with DMD, roughly 2-thirds are ages 9 and older, expects arbitration to commence in mid-2027, reduced its workforce by approximately 10% in the third quarter, reported approximately $198.5 million in cash, cash equivalents, restricted cash and marketable securities as of September 30, 2026, and believes its existing cash, cash equivalents and marketable securities are sufficient to fund operations for at least the next 12 months.

Capricor Therapeutics Risk Analysis

Capricor Therapeutics disclosed 31 risk factors in its most recent earnings report. Capricor Therapeutics reported the most risks in the "Finance & Corporate" category.

Higher RiskSector Avg.Lower RiskFinance & CorporateTech & InnovationLegal & RegulatoryProductionAbility to SellMacro & Political
Finance & Corporate - Financial and accounting risks. Risks related to the execution of corporate activity and strategy

Latest Risks Added

3 New Risks
1.We have a history of net losses, and we expect losses to continue for the foreseeable future. In addition, a number of factors may cause our operating results to fluctuate on a quarterly and annual basis, which may make it difficult to predict our future performance.Q2, 2026
2.If we enter into strategic partnerships, we may be required to relinquish important rights to and control over the development of our product candidates or otherwise be subject to terms unfavorable to us.Q2, 2026
3.If we achieve our near-term product development milestones, we may not be able to manage any subsequent growth.Q2, 2026

Capricor Therapeutics Peers Comparison

Overall Rating

UnderperformOutperform
Sector (51)

Financial Indicators

DE:4LN2 against its peers
NameOverall RatingMarket CapP/E RatioROEDividend YieldRevenue GrowthEPS Growth
Sector *51Neutral$7.86B-0.30-43.30%2.27%22.53%-2.21%
ABEOABEO50Neutral$140.30M-2.05-44.82%―9652.75%-172.49%
LXEOLXEO50Neutral$251.19M-2.67-41.85%――64.51%
RGNXRGNX50Neutral$508.48M-2.64-203.98%―-4.59%8.03%
RCKTRCKT45Neutral$268.95M-15.50-5.76%――93.45%
SLDBSLDB42Neutral$800.25M-4.25-67.78%――28.59%

* Healthcare Sector Average

Performance Comparison

0%200%400%DE:4LN2RCKTABEORGNXSLDBLXEODec '25Jan '26Feb '26Mar '26Apr '26May '26Jun '26Jul '26Aug '26Sep '26Oct '26Nov '26
DE:4LN2 and its peers over the selected period
Show on chartTickerCompany NamePriceChange% Change
DE:4LN2Capricor Therapeutics, Inc.8.954.0783.51%
RCKTRocket Pharma2.48-0.69-21.77%
ABEOAbeona Therapeutics Inc2.30-2.23-49.23%
RGNXRegenXBio Inc.8.47-3.17-27.23%
SLDBSolid Biosciences7.603.3076.74%
LXEOLexeo Therapeutics, Inc.3.07-5.92-65.85%
Glossary
BuyA stock rated as a "Buy" is expected to perform better than the overall market or a specific benchmark over the near-to-medium term. This rating suggests the stock is likely to deliver higher returns compared to other stocks in the same sector or market index. Note: This is not investment advice; please consult a financial advisor before making investment decisions.
HoldA stock rated as a "Hold" is expected to perform in line with the overall market or a specific benchmark. This rating indicates that the stock is neither particularly compelling nor unfavorable for investment. Note: This is not investment advice; please consult a financial advisor before making investment decisions.
SellA stock rated as a "Sell" is expected to perform worse than the overall market or a specific benchmark over the near-to-medium term. This rating suggests the stock may deliver lower returns compared to other stocks in the same sector or market index. Note: This is not investment advice; please consult a financial advisor before making investment decisions.

Disclaimer

This AI Analyst Stock Report is automatically generated by our AI systems using advanced algorithms and publicly available financial, technical, and market data. While the information provided aims to be accurate and insightful, it is intended for informational purposes only and should not be considered financial advice. Any content created by an AI (Artificial Intelligence) system may contain inaccuracies and/or contain errors. Investing in stocks carries inherent risks, and past performance is not indicative of future results. This report does not account for your personal financial circumstances, objectives, or risk tolerance. Always conduct your own research or consult with a qualified financial advisor before making investment decisions. The analysis and recommendations provided are based on historical and current data and may not fully reflect future market conditions or unexpected developments. Neither the creators of this report nor its affiliated entities guarantee the accuracy, completeness, or reliability of the information presented. Use this report at your own discretion and risk.