Capricor Therapeutics (CAPR)
NASDAQ:CAPR
Top Page
Capricor Therapeutics
(NASDAQ:CAPR)
Select Model
Select Model
Rating:61Neutral
Price Target:
$29.00
▼(-8.23% Downside)
Action:ReiteratedDate:03/18/26
The score is held back primarily by weak financial performance (persistent losses, cash burn, and severe revenue/TTM volatility). Offsetting this, technicals show strong upward price trend and the latest earnings call highlighted meaningful regulatory momentum (BLA acceptance/PDUFA date), strong pivotal data, and manufacturing readiness, while valuation remains unattractive due to unprofitability and no dividend.
Positive Factors
BLA acceptance with PDUFA date
Acceptance of the BLA and a defined PDUFA date materially reduces regulatory timing uncertainty and creates a clear commercialization timeline. This structural milestone moves the company from development toward potential approval, enabling planning for manufacturing, reimbursement discussions, and potential revenue generation if approved.
Negative Factors
Revenue dropped to zero
The collapse of reported revenue to zero underscores the company's lack of recurring commercial sales and dependence on one‑time milestone or collaboration receipts. Structurally, this makes future revenue timing and magnitude highly uncertain until product approval and commercialization are achieved, increasing financing sensitivity.
Read all positive and negative factors
Positive Factors
Negative Factors
BLA acceptance with PDUFA date
Acceptance of the BLA and a defined PDUFA date materially reduces regulatory timing uncertainty and creates a clear commercialization timeline. This structural milestone moves the company from development toward potential approval, enabling planning for manufacturing, reimbursement discussions, and potential revenue generation if approved.
Read all positive factors
Capricor Therapeutics (CAPR) vs. SPDR S&P 500 ETF (SPY)
Market Cap
$1.82B
Dividend YieldN/A
Average Volume (3M)1.45M
Price to Earnings (P/E)―
Beta (1Y)2.52
Revenue Growth-52.08%
EPS Growth-69.35%
CountryUS
Employees160
SectorHealthcare
Sector Strength45
IndustryBiotechnology
Share Statistics
EPS (TTM)-0.62
Shares Outstanding57,510,635
10 Day Avg. Volume992,315
30 Day Avg. Volume1,451,442
Financial Highlights & Ratios
PEG Ratio-0.13
Price to Book (P/B)4.39
Price to Sales (P/S)0.00
P/FCF Ratio-0.02
Enterprise Value/Market Cap0.65
Enterprise Value/RevenueN/A
Enterprise Value/Gross Profit-19.21
Enterprise Value/Ebitda-11.22
Forecast
1Y Price Target
$55.13Price Target Upside74.46% Upside
Rating ConsensusStrong Buy
Number of Analyst Covering8
EPS Forecast (FY)0.26
Revenue Forecast (FY)$129.66M
Capricor Therapeutics Business Overview & Revenue Model
Company Description
Capricor Therapeutics, Inc., a clinical-stage biotechnology company, focuses on the development of transformative cell and exosome-based therapeutics for the treatment and prevention of spectrum of diseases and disorders. Its lead candidate, CAP-1...
How the Company Makes Money
Capricor has historically generated little to no recurring commercial revenue because its lead programs have been in clinical development rather than broadly marketed products. When it reports revenue, it has primarily come from non-product source...
Capricor Therapeutics Earnings Call Summary
Earnings Call Date:Mar 12, 2026
(Q4-2025)
| % Change Since: |
Next Earnings Date:May 20, 2026
Earnings Call Sentiment Positive
The call conveyed predominantly positive operational and clinical developments: regulatory momentum with BLA acceptance and a clear PDUFA date, robust Phase 3 HOPE-3 efficacy and safety data (including a 91% slowing of LV ejection fraction decline and supportive functional and imaging endpoints), manufacturing readiness and planned capacity expansion, and recent financings and NASDAQ uplisting to support near-term execution. Counterbalancing these positives are biotech-typical near-term challenges—zero product revenue, materially higher operating expenses and widened net losses in 2025, remaining labeling and regulatory uncertainties, limited neutralization signals in the early StealthX readout, and a manufacturing ramp timeline that may constrain supply until expansions come online. Overall, the strategic and clinical wins (BLA acceptance, pivotal data, manufacturing inspection success, strengthened capital base) outweigh the financial and programmatic risks discussed on the call.Positive Updates
BLA Acceptance and PDUFA Date
FDA accepted the company's Class II BLA resubmission for deramycin and assigned a PDUFA target action date of 2026-08-22, marking a major regulatory milestone toward potential approval.
Negative Updates
Revenue Decline to Zero
Revenue for 2025 was $0 (versus $11.1M in 2024); full-year revenue 2025 was $0 compared to $22.3M in 2024 (a 100% year-over-year decline) as prior milestone/upfront payments were fully recognized in 2024.
Read all updates
Q4-2025 Updates
Positive
Negative
BLA Acceptance and PDUFA Date
FDA accepted the company's Class II BLA resubmission for deramycin and assigned a PDUFA target action date of 2026-08-22, marking a major regulatory milestone toward potential approval.
Read all positive updates
Company Guidance
Management said the resubmitted BLA was accepted and assigned a PDUFA target action date of August 22, 2026, supported by the pivotal HOPE‑3 trial (106 patients) which met its primary PUL endpoint and all Type‑1‑error‑controlled secondary endpoints, with left ventricular ejection fraction showing a 91% slowing of disease progression (statistically significant overall and p=0.01 in the cardiomyopathy subgroup); the program has >800 IV infusions across studies, >100 OLE patients (some on continuous infusions up to five years), and manufacturing passed the FDA pre‑license inspection with all Form‑483s addressed and current capacity to support ~250 patients/year (with stockpiling plans) and an expansion (≈6 additional clean rooms) expected to support ~2,500 patients/year or ~10,000 doses annually coming online in late‑2027; financially the company reported cash of approximately $318,000,000 as of 12/31/2025 (the CFO also reported cash, cash & marketable securities of ~$3.181 billion), received $162,000,000 net proceeds from a December offering and drew $75,000,000 under an ATM, had 2025 revenue of $0 (vs ~$22.3M FY‑2024), FY‑2025 operating expenses of ~$108.1M (vs $64.8M FY‑2024) and a FY‑2025 net loss of ~$105.0M (vs $40.5M FY‑2024), believes current capital funds operations into 2027, and noted eligibility for a transferable priority review voucher (sunset 09/30/2029) upon approval.Capricor Therapeutics Financial Statement Overview
Summary
Income Statement
9
Very Negative
Balance Sheet
18
Very Negative
Cash Flow
10
Very Negative
| Breakdown | Dec 2025 | Dec 2024 | Dec 2023 | Dec 2022 | Dec 2021 |
|---|---|---|---|---|---|
Income Statement | |||||
| Total Revenue | 0.00 | 22.27M | 25.18M | 2.55M | 244.90K |
| Gross Profit | 0.00 | -27.70M | -11.27M | -19.27M | 244.90K |
| EBITDA | -108.14M | -41.14M | -23.01M | -29.16M | -20.69M |
| Net Income | -105.04M | -40.47M | -22.29M | -29.02M | -20.02M |
Balance Sheet | |||||
| Total Assets | 355.95M | 170.48M | 58.73M | 50.09M | 41.33M |
| Cash, Cash Equivalents and Short-Term Investments | 318.13M | 151.52M | 39.49M | 41.42M | 34.89M |
| Total Debt | 20.94M | 1.45M | 2.24M | 2.56M | 2.87M |
| Total Liabilities | 50.16M | 25.02M | 36.13M | 38.31M | 9.96M |
| Stockholders Equity | 305.79M | 145.46M | 22.60M | 11.79M | 31.37M |
Cash Flow | |||||
| Free Cash Flow | -72.72B | -41.53M | -27.64M | 1.56M | -18.01M |
| Operating Cash Flow | -69.81B | -40.00M | -25.60M | 4.92M | -16.81M |
| Investing Cash Flow | 97.48B | -116.18M | 5.11M | -35.07M | -1.20M |
| Financing Cash Flow | 248.89B | 152.77M | 25.58M | 4.87M | 20.23M |
Capricor Therapeutics Technical Analysis
Positive
31.60
Price Trends
27.72
Positive
24.20
Positive
15.74
Positive
Market Momentum
0.90
Negative
57.34
Neutral
75.27
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 31.6 is above the 20-day moving average (MA) of 30.69, above the 50-day MA of 27.72, and above the 200-day MA of 15.74, indicating a bullish trend. The MACD of 0.90 indicates Negative momentum. The RSI at 57.34 is Neutral, neither overbought nor oversold. The STOCH value of 75.27 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 75 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 |
|---|---|---|---|---|---|---|---|
61 Neutral | $1.82B | ― | -67.52% | ― | -52.08% | -69.35% | |
52 Neutral | $515.62M | -3.10 | -47.27% | ― | ― | ― | |
51 Neutral | $7.86B | -0.30 | -43.30% | 2.27% | 22.53% | -2.21% | |
51 Neutral | $267.08M | -1.12 | -224.96% | ― | 12.26% | 37.36% | |
44 Neutral | $144.65M | ― | -424.76% | ― | ― | 82.23% | |
43 Neutral | $146.14M | -8.62 | 25.65% | ― | ― | 18.82% |
* Healthcare Sector Average
CAPR
Capricor Therapeutics
31.60
22.72
255.86%
GALT
Galectin Therapeutics
2.22
0.93
72.09%
ALEC
Alector
2.42
1.52
167.70%
FDMT
4D Molecular Therapeutics
10.10
7.51
289.96%
HUMA
Humacyte
0.65
-0.92
-58.54%
Capricor Therapeutics Corporate Events
Business Operations and StrategyProduct-Related AnnouncementsRegulatory Filings and Compliance
Capricor Advances Deramiocel BLA Review for Duchenne DMD
Positive
Mar 10, 2026
On March 10, 2026, Capricor Therapeutics said the U.S. Food and Drug Administration lifted a prior Complete Response Letter and resumed review of its Biologics License Application for Deramiocel, an investigational cell therapy for Duchenne muscul...
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.