This is a pre-revenue, cash-burning single-asset pipeline company with three earnings misses in four quarters, a quality score far below the minimum acceptable floor, and extreme bearish positioning — the sizable analyst upside is entirely contingent on a single regulatory event for Deramiocel, making this a high-risk binary situation rather than a conventional investment.
Thesis pillars
- Single Asset Pipeline Binary Risk↓Deteriorating
- Extreme Bearish Market Positioning↓Deteriorating
- Cash Burn With Worsening Misses↓Deteriorating
- +1 more pillar — see the Why tab for full reasoning
Pillars as of Jul 3, 2026, based on the 10-K filed Mar 17, 2026
Capricor Therapeutics, Inc. (CAPR) Stock Analysis
Falling Knife setup
Healthcare · Biotechnology
Hold if already holding. Not a fresh buy at $5.74, but acceptable to hold if already in. Reasons: Concentration risk — Pipeline: Deramiocel; Concentration risk — Supplier: donor hearts.
Capricor Therapeutics develops Deramiocel, a cell therapy for Duchenne muscular dystrophy, with a BLA under FDA review (PDUFA August 22, 2026) as its sole near-term commercial asset; no products are approved for sale. If approved, Nippon Shinyaku holds exclusive U.S. and Japan... Read more
Hold if already holding. Not a fresh buy at $5.74, but acceptable to hold if already in. Reasons: Concentration risk — Pipeline: Deramiocel; Concentration risk — Supplier: donor hearts. Chart setup: Death cross, below all MAs, RSI 28, MACD bearish. Market cap $334M below $400M minimum. Not in investable universe. Score 4.3/10, moderate confidence.
Passes 5/9 gates (clean insider activity, no SEC red flags, news events none recent, semi cycle peak clear, materials cycle peak clear). Fails on weak momentum and death cross (50MA < 200MA). Suitability: speculative.
About Capricor Therapeutics, Inc.
About Capricor Therapeutics, Inc.
Capricor Therapeutics has a single clinical asset approaching potential commercialization: Deramiocel, a cell therapy for Duchenne muscular dystrophy, with a Biologics License Application under FDA review and a PDUFA target action date of August 22, 2026. The HOPE-3 Phase 3 trial enrolled 106 participants across 20 U.S. clinical sites and reported in December 2025 that the primary PUL v2.0 endpoint achieved 54% slowing of disease progression (p=0.029) and the key cardiac endpoint of left ventricular ejection fraction achieved 91% slowing of decline (p=0.041). The company held approximately $318.1 million in cash as of December 31, 2025, with no approved products and no commercial revenue.
Capricor's revenue path depends entirely on FDA approval of Deramiocel and subsequent commercialization, for which Nippon Shinyaku Co., Ltd. holds exclusive distribution rights in the United States and Japan. Manufacturing relies on cardiosphere-derived cells isolated from donated human hearts, creating supply chain dependency on the availability of qualified donor hearts and other raw materials at the company's San Diego facility. The exosome platform (StealthX) is in a Phase 1 clinical study for a SARS-CoV-2 vaccine candidate sponsored by the National Institute of Allergy and Infectious Diseases, with final results expected in Q2 2026. Additional exosome therapeutic programs remain in discovery. Capricor has received approximately $600 million in cumulative funding since inception from equity financings, collaborations, grants, and government programs including NIAID, NIH, DoD, and CIRM.
Show full overview
The commercial timeline depends on a single FDA decision. The original BLA received a Complete Response Letter in July 2025 citing insufficient evidence of effectiveness; following a Type A meeting with the FDA in August 2025, Capricor submitted a Class 2 resubmission that was accepted with a new PDUFA of August 22, 2026. A second refusal or further delay would materially extend the funding runway requirement. In March 2026, additional HOPE-3 cardiac MRI data presented at the Muscular Dystrophy Association Clinical & Scientific Conference showed a statistically significant reduction in myocardial fibrosis, which may support the resubmission case.
See also: Healthcare · Biotechnology
From Capricor Therapeutics, Inc.'s most recent 10-K filing, extracted June 9, 2026.
Recent developments
updated 2026-10-27Recent Developments — Capricor Therapeutics, Inc.
Latest news
- NEWS What's Going On With Capricor Therapeutics Stock Monday? — benzinga Oct 5, 2026 neutral
- NEWS Capricor Therapeutics Presents New Data From Ongoing HOPE-3 OLE Study For Its Lead Asset, Deramiocel, For Treatment Of U — benzinga Oct 5, 2026 positive
- NEWS Capricor Therapeutics Stock Surges: What's Going On? — benzinga Sep 30, 2026 positive
- NEWS Hewlett Packard Enterprise, Capital Bancorp, FormFactor And Other Big Stocks Moving Higher On Wednesday — benzinga Sep 30, 2026 neutral
- NEWS Why FingerMotion Shares Are Trading Higher By Around 18%; Here Are 20 Stocks Moving Premarket — benzinga Sep 30, 2026 neutral
Generated 2026-10-27T12:09:16Z.
Upcoming dated catalysts
Thesis
Key Metrics
Quality Signals
Options Flow
Concentration Risks(10-K Item 1A)
- HIGHpipelineDeramiocel10-K Item 1: 'Deramiocel is Capricor's lead product candidate and is being developed for the treatment of DMD'
- HIGHSupplierdonor hearts10-K Item 1A: 'the manufacturing of our product candidates is dependent on complex supply chains, including the availability of donor hearts and other raw materials that are critical'
- HIGHcounterpartyNippon Shinyaku10-K Item 1A: 'we will depend on the ability of Nippon Shinyaku to perform according to the terms of the U.S. Distribution and Japan Distribution Agreements'
Model-generated analysis — not investment advice. Not a registered investment advisor. Past performance does not guarantee future results. How we score · Editorial policy
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Rating Breakdown
4 floor-breakers
Price action weak — below key moving averages, no momentum carry. Needs a base before trend-continuation setups apply.static
Quality below the gate floor. Component breakdown shows what dragged the score down.static
No near-term catalyst priced in. Thesis progression will come from fundamentals grinding, not event reaction.static
Ranks in the bottom of its industry peers on the composite signal. Better names in the same sector exist.static
Price Targets
Position Sizing
Risk Alerts
Earnings
Verdict History
Frequently Asked Questions
Hold if already holding. Not a fresh buy at $5.74, but acceptable to hold if already in. Reasons: Concentration risk — Pipeline: Deramiocel; Concentration risk — Supplier: donor hearts. Chart setup: Death cross, below all MAs, RSI 28, MACD bearish. Market cap $334M below $400M minimum. Not in investable universe. Resistance target $10.51 (+83.1%), stop $5.51 (−4.2%), A.R:R 0.0:1. Score 4.3/10, moderate confidence.
Resistance target: $10.51 (+83.1% upside). Resistance target $10.51 (+83.1%), stop $5.51 (−4.2%), A.R:R 0.0:1. Stop-loss: $5.51.
Concentration risk — Pipeline: Deramiocel; Concentration risk — Supplier: donor hearts; DATA_ISSUE: analyst_target_implausible (raw $27.00 vs price $5.74 — ratio 4.7×). Rejected, falling back to technical TP..
Capricor Therapeutics, Inc. trades at a P/E of N/A (forward -4.0). TrendMatrix value score: 5.0/10. Verdict: Hold.
16 analysts cover CAPR with a consensus score of 3.8/5. Average price target: $27.
What does Capricor Therapeutics, Inc. do?Capricor Therapeutics develops Deramiocel, a cell therapy for Duchenne muscular dystrophy, with a BLA under FDA review...
Capricor Therapeutics develops Deramiocel, a cell therapy for Duchenne muscular dystrophy, with a BLA under FDA review (PDUFA August 22, 2026) as its sole near-term commercial asset; no products are approved for sale. If approved, Nippon Shinyaku holds exclusive U.S. and Japan distribution rights. The company held approximately $318.1 million in cash at December 31, 2025.