Capricor Therapeutics, Inc. (CAPR)
NASDAQ:CAPR
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Capricor Therapeutics
(NASDAQ:CAPR)
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Rating:51Neutral
Price Target:
$28.00
▼(-19.31% Downside)
Action:Reiterated
Date:05/20/26
The score is held down primarily by weak financial performance (ongoing losses, recent zero revenue, and heavy cash burn) and bearish technical signals. These are partially offset by a constructive earnings-call outlook driven by Phase 3 efficacy, an active FDA review with a defined PDUFA date, and management’s stated cash runway, though legal and commercialization risks remain significant.
Positive Factors
Pivotal Phase 3 efficacy (HOPE‑3)
Statistically significant Phase 3 results provide durable clinical validation for deramiocel across skeletal and cardiac endpoints, materially improving the likelihood of regulatory approval, payor engagement and clinician adoption. This reduces development risk and supports long‑term commercial potential if labeled.
Negative Factors
Litigation over U.S. distribution rights
Active litigation over U.S. distribution creates material, persistent commercial uncertainty: it could delay launch, require repayment of $50M, force re‑negotiation of commercialization plans, and divert management focus. The outcome directly affects the company’s ability to realize and monetize deramiocel revenue streams.
Read all positive and negative factors
Positive Factors
Negative Factors
Pivotal Phase 3 efficacy (HOPE‑3)
Statistically significant Phase 3 results provide durable clinical validation for deramiocel across skeletal and cardiac endpoints, materially improving the likelihood of regulatory approval, payor engagement and clinician adoption. This reduces development risk and supports long‑term commercial potential if labeled.
Read all positive factors
Capricor Therapeutics (CAPR) vs. SPDR S&P 500 ETF (SPY)
Market Cap
$1.67B
Dividend YieldN/A
Average Volume (3M)1.09M
Price to Earnings (P/E)―
Beta (1Y)2.17
Revenue Growth-100.00%
EPS Growth-62.96%
CountryUS
Employees160
SectorHealthcare
Sector Strength45
IndustryBiotechnology
Share Statistics
EPS (TTM)-2.32
Shares Outstanding57,911,892
10 Day Avg. Volume1,088,407
30 Day Avg. Volume1,090,294
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 Cap0.74
Enterprise Value/RevenueN/A
Enterprise Value/Gross Profit-29.14
Enterprise Value/Ebitda-10.54
Forecast
1Y Price Target
$54.50Price Target Upside57.06% Upside
Rating ConsensusStrong Buy
Number of Analyst Covering8
EPS Forecast (FY)-0.34
Revenue Forecast (FY)$127.58M
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:May 12, 2026
(Q1-2026)
| % Change Since: |
Next Earnings Date:Aug 12, 2026
Earnings Call Sentiment Positive
The call conveyed strong clinical and regulatory progress for deramiocel — statistically significant phase 3 efficacy (primary and cardiac secondary endpoints), robust long-term safety exposure, active BLA review with a clear PDUFA date, in-house manufacturing capabilities and a solid cash runway. Management also articulated a concrete commercialization plan and eligibility for a monetizable Priority Review Voucher. Offsetting these positives are notable near-term risks: an active lawsuit with NS Pharma that creates distribution uncertainty (and potential need to repay $50M), rising operating expenses and no current product revenue, manufacturing labeling constraints for an ultra-cold-chain therapy, and unresolved ASP/AMP payer complexities that could affect access. On balance, the material clinical/regulatory achievements and internal control of manufacturing and cash resources outweigh the legal and commercial execution risks, but the litigation and payer/pricing issues remain important near-term uncertainties.Positive Updates
Pivotal Phase 3 Efficacy — HOPE-3 Met Primary Endpoint
HOPE-3 (n=106) met its primary endpoint (PUL v2.0) with ~54% reduction in disease severity at 12 months (p=0.029). All type-1-error controlled secondary endpoints were also significant, supporting clinical benefit in Duchenne muscular dystrophy (DMD).
Negative Updates
Litigation with NS Pharma / Nippon Shinyaku
Capricor filed suit (May 7, 2026) seeking rescission of the U.S. distribution agreement and a preliminary injunction to permit Capricor to distribute deramiocel. Litigation introduces material uncertainty around commercial distribution and timing; outcome depends on court rulings.
Read all updates
Q1-2026 Updates
Positive
Negative
Pivotal Phase 3 Efficacy — HOPE-3 Met Primary Endpoint
HOPE-3 (n=106) met its primary endpoint (PUL v2.0) with ~54% reduction in disease severity at 12 months (p=0.029). All type-1-error controlled secondary endpoints were also significant, supporting clinical benefit in Duchenne muscular dystrophy (DMD).
Read all positive updates
Company Guidance
Management said the deramiocel BLA resubmission (classified as a Class 2, accepted as complete) is under active FDA review with a PDUFA target action date of August 22, 2026 and near‑term labeling discussions expected; they highlighted HOPE‑3 Phase 3 results from 106 patients (1:1 randomization) showing ~54% reduction in disease severity on PUL v2.0 at 12 months (p=0.029), LVEF slowing of ~91% in all evaluable patients and ~120% in the cardiomyopathy subset (p=0.01), noted >800 IV infusions completed and ~90 open‑label extension patients with up to 5 years of dosing supporting safety, and said FDA information requests have been primarily CMC/clinical clarifications; commercial and manufacturing guidance included an in‑house PLI‑inspected facility able to support ~200–250 patients/year (≈1,000 doses/year at 4 doses/patient), a planned expansion to ~2,000–2,500 patients/year (~10,000 doses/year) with full validation targeted in 2027, plans to stockpile commercial doses once labeling is set (including an interim label solution for the ultracold product), upcoming EMA/PMDA engagements, potential receipt/monetization of a Priority Review Voucher upon approval, and financials of ~$279M cash (3/31/2026) with Q1 2026 operating expenses of ~$36.8M (vs ~$25M in Q1 2025) and a Q1 2026 net loss of ~$33.9M ($0.59/share), which management believes provides runway into 2027.Capricor Therapeutics Financial Statement Overview
Summary
Income Statement
18
Very Negative
Balance Sheet
62
Positive
Cash Flow
21
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 | -42.41M | 0.00 | -27.70M | -11.27M | -19.27M | 244.90K |
| EBITDA | -117.24M | -108.14M | -41.14M | -23.01M | -29.16M | -20.69M |
| Net Income | -114.59M | -105.04M | -40.47M | -22.29M | -29.02M | -20.02M |
Balance Sheet | ||||||
| Total Assets | 326.28M | 355.95M | 170.48M | 58.73M | 50.09M | 41.33M |
| Cash, Cash Equivalents and Short-Term Investments | 278.61M | 318.13M | 151.52M | 39.49M | 41.42M | 34.89M |
| Total Debt | 21.12M | 20.94M | 1.45M | 2.24M | 2.56M | 2.87M |
| Total Liabilities | 47.58M | 50.16M | 25.02M | 36.13M | 38.31M | 9.96M |
| Stockholders Equity | 278.70M | 305.79M | 145.46M | 22.60M | 11.79M | 31.37M |
Cash Flow | ||||||
| Free Cash Flow | -113.96M | -72.72B | -41.53M | -27.64M | 1.56M | -18.01M |
| Operating Cash Flow | -92.63M | -69.81B | -40.00M | -25.60M | 4.92M | -16.81M |
| Investing Cash Flow | -81.05M | 97.48B | -116.18M | 5.11M | -35.07M | -1.20M |
| Financing Cash Flow | 250.31M | 248.89B | 152.77M | 25.58M | 4.87M | 20.23M |
Capricor Therapeutics Technical Analysis
Neutral
34.70
Price Trends
31.66
Negative
28.77
Positive
19.58
Positive
Market Momentum
-1.06
Positive
42.86
Neutral
43.95
Neutral
Evaluating momentum and price trends is crucial in stock analysis to make informed investment decisions. For CAPR, the sentiment is Neutral. The current price of 34.7 is above the 20-day moving average (MA) of 31.30, above the 50-day MA of 31.66, and above the 200-day MA of 19.58, indicating a neutral trend. The MACD of -1.06 indicates Positive momentum. The RSI at 42.86 is Neutral, neither overbought nor oversold. The STOCH value of 43.95 is Neutral, not indicating any strong overbought or oversold conditions. Overall, these indicators collectively point to a Neutral sentiment for CAPR.
Capricor Therapeutics Risk Analysis
Capricor Therapeutics disclosed 30 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 |
|---|---|---|---|---|---|---|---|
51 Neutral | $7.86B | -0.30 | -43.30% | 2.27% | 22.53% | -2.21% | |
51 Neutral | $1.67B | -12.86 | -59.27% | ― | -100.00% | -62.96% | |
50 Neutral | $449.58M | -2.30 | -36.83% | ― | 383560.87% | 20.87% | |
50 Neutral | $233.12M | -1.70 | -2781.56% | ― | 289.94% | 16.60% | |
42 Neutral | $245.37M | ― | -295.17% | ― | -79.15% | 5.68% | |
41 Neutral | $164.64M | -9.09 | 21.05% | ― | ― | 43.38% |
* Healthcare Sector Average
CAPR
Capricor Therapeutics
28.87
18.62
181.66%
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Capricor Therapeutics Corporate Events
Business Operations and StrategyLegal Proceedings
Capricor Sues NS Pharma Over Deramiocel U.S. Rights
Negative
May 7, 2026
On May 7, 2026, Capricor Therapeutics filed a lawsuit in the Superior Court of New Jersey against Nippon Shinyaku and its U.S. unit NS Pharma over their U.S. distribution agreement for Deramiocel, its investigational Duchenne muscular dystrophy th...
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.