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Capricor Therapeutics
(NASDAQ:CAPR)
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Rating:48Neutral
Price Target:
$9.50
▲(14.60% Upside)
Action:Reiterated
Date:10/01/26
The score is primarily held down by weak financial performance (zero/limited revenue visibility, persistent losses, and ongoing cash burn with rising debt). Technicals are mixed with only modest near-term support and weak longer-term trend positioning. The earnings call adds offsetting positives from clinical progress and a strong cash position, but regulatory uncertainty and accelerating expenses keep the overall risk profile elevated; valuation offers limited support given negative earnings and no dividend.
Positive Factors
Statistically significant primary efficacy
The positive HOPE-3 primary endpoint provides clinically relevant evidence for deramiocel’s ability to preserve upper-limb function in DMD. A successful pivotal result, reinforced by peer review, can support regulatory review and create a foundation for future commercialization if approval is secured.
Negative Factors
FDA review delay
A three-month regulatory delay extends the period before Capricor can potentially begin commercial sales and increases the time the company must fund development and launch preparation without product revenue. It also signals that the amendment requires substantial additional FDA review.
Read all positive and negative factors
Positive Factors
Negative Factors
Statistically significant primary efficacy
The positive HOPE-3 primary endpoint provides clinically relevant evidence for deramiocel’s ability to preserve upper-limb function in DMD. A successful pivotal result, reinforced by peer review, can support regulatory review and create a foundation for future commercialization if approval is secured.
Read all positive factors
Capricor Therapeutics (CAPR) vs. SPDR S&P 500 ETF (SPY)
Market Cap
$520.34M
Dividend YieldN/A
Average Volume (3M)5.49M
Price to Earnings (P/E)―
Beta (1Y)2.02
Revenue Growth-100.00%
EPS Growth-49.28%
CountryUS
Employees231
SectorHealthcare
Sector Strength45
IndustryBiotechnology
Share Statistics
EPS (TTM)-2.45
Shares Outstanding58,138,990
10 Day Avg. Volume4,481,453
30 Day Avg. Volume5,485,797
Financial Highlights & Ratios
PEG Ratio-0.13
Price to Book (P/B)4.39
Price to Sales (P/S)0.00
P/FCF Ratio-18.45
Enterprise Value/Market Cap2.40
Enterprise Value/RevenueN/A
Enterprise Value/Gross Profit-61.30
Enterprise Value/Ebitda1.06
Forecast
1Y Price Target
$27.00Price Target Upside225.69% Upside
Rating ConsensusModerate Buy
Number of Analyst Covering10
EPS Forecast (FY)-1.55
Revenue Forecast (FY)$91.62M
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...
How the Company Makes Money
As a clinical-stage biotechnology company, Capricor has historically generated little to no recurring revenue from product sales because its lead candidates have been in development and not broadly commercialized. When revenue is present, it is ty...
Capricor Therapeutics Earnings Call Summary
Earnings Call Date:Aug 13, 2026
(Q2-2026)
| % Change Since: |
Next Earnings Date:Nov 17, 2026
Earnings Call Sentiment Neutral
The call balanced meaningful clinical and regulatory progress (Lancet publication, statistically significant primary HOPE‑3 endpoint for upper limb function, established safety exposure, operational in‑house manufacturing and $237.9M cash) against substantial near‑term challenges (AdCom vote against the cardiomyopathy question, mixed secondary endpoint results, no revenue, rising operating expenses and widening losses, a Form 483 observation, paused non‑Daramycin pipeline work, and an ongoing commercial dispute with NS Pharma). Management has a clear path to submit an amendment focused on the primary skeletal muscle indication and the FDA indicated willingness to review it, but regulatory and financial risks remain in the near term.Positive Updates
Regulatory Path Forward and PDUFA Timeline
BLA for Daramycin under FDA review with current PDUFA action date of August 22, 2026; company plans to submit a BLA amendment including 24-month open‑label extension data to pursue a refined upper‑limb skeletal muscle indication and FDA indicated willingness to review the amendment and extend the PDUFA date.
Negative Updates
Advisory Committee Vote Against Cardiomyopathy Indication
FDA Cellular, Tissue and Gene Therapies Advisory Committee voted 3 in favor, 9 against (0 abstentions) on whether available evidence provides substantial evidence of effectiveness for cardiomyopathy in DMD — a significant setback for the originally requested cardiomyopathy indication.
Read all updates
Q2-2026 Updates
Positive
Negative
Regulatory Path Forward and PDUFA Timeline
BLA for Daramycin under FDA review with current PDUFA action date of August 22, 2026; company plans to submit a BLA amendment including 24-month open‑label extension data to pursue a refined upper‑limb skeletal muscle indication and FDA indicated willingness to review the amendment and extend the PDUFA date.
Read all positive updates
Company Guidance
Management said the Daramycin BLA remains under FDA review with a current PDUFA target action date of August 22, 2026 and noted an FDA advisory committee vote of 3–9 against approval for the cardiomyopathy indication; they plan to submit a BLA amendment (timing being finalized) that adds 24‑month open‑label extension data and additional analyses, after which the FDA has indicated it may extend the PDUFA date. They highlighted HOPE‑3 results showing a statistically significant primary upper‑limb (PUL 2.0) benefit — a 4.5% mean treatment difference (1.2 absolute change), p=0.029 — and key secondary left ventricular ejection fraction effects of 2.4 percentage points (p=0.04) on top‑line, 1.8 points (p=0.09) under the prespecified model, and a cardiomyopathy subgroup result of 2.8 points (p=0.02). The program has delivered ~1,300 IV infusions across >200 patients in 3 trials, >80 patients in open‑label extensions (some on continuous infusions >5 years), and the Phase 3 data were published in The Lancet; FDA BIMO inspection yielded one Form 483 to which the company has responded. Financially, Capricor had $237.9M in cash, cash equivalents and marketable securities as of 6/30/2026, reported no revenue in Q2 2026 or Q2 2025, Q2 operating expenses of $42.9M (vs $27.7M year‑ago), Q2 net loss of ~$40.7M ($0.70/share) (vs ~$25.9M, $0.57/share), six‑month net loss of $74.7M (vs $50.3M), and an accumulated deficit of ~$379.6M; commercial launch planning is being paced, the in‑house GMP facility in San Diego is operational, and second‑floor expansion validation/approval is estimated in 2027, while arbitration with NS Pharma is expected to begin this fall.Capricor Therapeutics Financial Statement Overview
Summary
Income Statement
18
Very Negative
Balance Sheet
56
Neutral
Cash Flow
24
Negative
| Breakdown | TTM | Dec 2025 | Dec 2024 | Dec 2023 | Dec 2022 | Dec 2021 |
|---|---|---|---|---|---|---|
Income Statement | ||||||
| Total Revenue | 0.00 | 0.00 | 22.27M | 25.18M | 2.55M | 244.90K |
| Gross Profit | -20.36M | 0.00 | -27.70M | -11.27M | -19.27M | 244.90K |
| EBITDA | 1.17B | -100.11M | -39.04M | -21.22M | -28.49M | -19.78M |
| Net Income | -129.42M | -105.04M | -40.47M | -22.29M | -29.02M | -20.02M |
Balance Sheet | ||||||
| Total Assets | 368.74M | 355.95M | 170.48M | 58.73M | 50.09M | 41.33M |
| Cash, Cash Equivalents and Short-Term Investments | 237.93M | 318.13M | 151.52M | 39.49M | 41.42M | 34.89M |
| Total Debt | 91.05M | 17.94M | 4.83M | 5.61M | 5.94M | 6.25M |
| Total Liabilities | 122.52M | 50.16M | 25.02M | 36.13M | 38.31M | 9.96M |
| Stockholders Equity | 246.22M | 305.79M | 145.46M | 22.60M | 11.79M | 31.37M |
Cash Flow | ||||||
| Free Cash Flow | -129.78M | -72.72M | -41.53M | -27.64M | 1.56M | -18.01M |
| Operating Cash Flow | -104.00M | -69.81M | -40.00M | -25.60M | 4.92M | -16.81M |
| Investing Cash Flow | -144.36M | 97.48M | -116.18M | 5.11M | -35.07M | -1.20M |
| Financing Cash Flow | 246.05M | 248.89M | 152.77M | 25.58M | 4.87M | 20.23M |
Capricor Therapeutics Technical Analysis
Positive
8.29
Price Trends
7.74
Positive
16.71
Negative
22.70
Negative
Market Momentum
-0.07
Negative
49.75
Neutral
37.72
Neutral
Evaluating momentum and price trends is crucial in stock analysis to make informed investment decisions. For CAPR, the sentiment is Positive. The current price of 8.29 is below the 20-day moving average (MA) of 8.83, above the 50-day MA of 7.74, and below the 200-day MA of 22.70, indicating a neutral trend. The MACD of -0.07 indicates Negative momentum. The RSI at 49.75 is Neutral, neither overbought nor oversold. The STOCH value of 37.72 is Neutral, not indicating any strong overbought or oversold conditions. Overall, these indicators collectively point to a Positive sentiment for CAPR.
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.
Finance & Corporate - Financial and accounting risks. Risks related to the execution of corporate activity and strategy
Latest Risks Added 0 New Risks
Capricor Therapeutics Peers Comparison
UnderperformOutperform
Sector (51)
Name | Overall Rating | Market Cap | P/E Ratio | ROE | Dividend Yield | Revenue Growth | EPS Growth |
|---|---|---|---|---|---|---|---|
56 Neutral | $755.19M | -5.03 | -41.33% | ― | 278712.12% | 26.59% | |
54 Neutral | $393.31M | -9.13 | 21.48% | ― | ― | 33.25% | |
51 Neutral | $7.86B | -0.30 | -43.30% | 2.27% | 22.53% | -2.21% | |
48 Neutral | $520.34M | -3.65 | -56.60% | ― | -100.00% | -49.28% | |
48 Neutral | $144.87M | -1.02 | -938.20% | ― | 159.29% | -7.39% | |
46 Neutral | $202.10M | -1.65 | -531.04% | ― | -82.91% | 6.27% |
* Healthcare Sector Average
CAPR
Capricor Therapeutics
8.95
1.14
14.60%
GALT
Galectin Therapeutics
3.90
-0.54
-12.16%
ALEC
Alector
1.81
-1.37
-43.08%
FDMT
4D Molecular Therapeutics
13.67
5.27
62.74%
HUMA
Humacyte
0.52
-1.96
-78.99%
Capricor Therapeutics Corporate Events
Business Operations and StrategyProduct-Related AnnouncementsRegulatory Filings and Compliance
Capricor Therapeutics Faces FDA Delay for Deramiocel Review
Negative
Aug 24, 2026
On August 24, 2026, Capricor Therapeutics announced that the U.S. Food and Drug Administration extended the Prescription Drug User Fee Act target action date for its Biologics License Application for Deramiocel, an investigational cell therapy for...
Business Operations and StrategyRegulatory Filings and Compliance
Capricor Faces FDA Panel Setback on Deramiocel Therapy
Negative
Jul 30, 2026
On July 29, 2026, the FDA’s Cellular, Tissue and Gene Therapies Advisory Committee concluded that current evidence does not support the effectiveness of Capricor Therapeutics‘ Deramiocel for treating cardiomyopathy in Duchenne muscular...
Business Operations and StrategyProduct-Related AnnouncementsRegulatory Filings and Compliance
Lancet Validates Capricor’s HOPE-3 Duchenne Trial Results
Positive
Jul 29, 2026
On July 29, 2026, Capricor reported that The Lancet published the final one-year results from its Phase 3 HOPE-3 trial of Deramiocel in Duchenne muscular dystrophy, confirming the study met its primary endpoint with a 54% slowing of upper limb fun...
Business Operations and Strategy
Capricor Therapeutics Signs Strategic Headquarters Lease Agreement
Positive
Jul 15, 2026
On July 9, 2026, Capricor Therapeutics signed a lease for approximately 171,000 rentable square feet at 9625 Towne Centre Drive in San Diego to serve as its new headquarters with expanded manufacturing, RD labs and corporate offices. The lease ter...
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.